44 Quality Assurance jobs in Singapore

**Associate Quality Assurance**
**Amgen Singapore Manufacturing**
**HOW MIGHT YOU DEFY IMAGINATION?**
Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an **Associate Quality Assurance** in **Amgen Singapore Manufacturing** .
**Live**
**What you will do**
The Incoming Quality Assurance (IQA) Associate position will provide support for the IQA team, which is part of the Lot Disposition group of the Quality Assurance function. The role will be based out of Amgen Singapore Manufacturing (ASM) or one of its partner 3rd Party Logistics Service Provider (LSP) and will work under the general supervision of the hiring manager.
The IQA team provides expertise in performing inspection, sampling and testing of incoming materials to meet Amgen specifications and ensure a constant supply of raw materials for ASM. The team provides these crucial services to ensure only the highest quality raw materials are used to create products for our patients.
Main Responsibilities:
+ Comply with safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
+ Complete required assigned training prior to execution of required tasks
+ Perform raw material inspection, sampling and rapid ID testing in accordance to written SOPs and Methods.
+ Generate complete and accurate documentation using electronic or handwritten systems.
+ Review records to ensure raw materials are tested and inspected according to specification and SOPs
+ Perform business operations related to inspection/sampling/testing (i.e updating dashboards, relevant metrics, housekeeping, inventory management, audit support)
+ Support site/network Continual Improvement initiatives
+ Ensures facilities, equipment, materials and procedures comply with cGMP practices and other applicable regulations
+ Alert management of quality, compliance, supply and safety risks in a timely manner
+ Participate in raw material issues or deviations
+ Performs additional duties as specified by management
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
**Win**
**What we expect of you**
**Basic Qualifications**
+ Bachelor's Degree and 2 years of directly related experience OR
+ Associate's Degree and 4 years of directly related experience OR
+ High School Diploma / GED and 6 years of directly related experience
+ 2 years of experience in regulated environment
+ Experience and basic troubleshooting skills with laboratory and process equipment
+ Experience with LIMS, SAP, TrackWise
+ Ability to understand, apply and evaluate basic chemistry
+ Ability to adhere to regulatory requirements, written procedures and safety guidelines
+ Ability to evaluate documentation/data according to company and regulatory guidelines
+ Ability to interact with inspectors (internal and external)
+ Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
+ Ability to organize work, handle multiple priorities and meet deadlines
+ Detail oriented as well as flexible and adaptable to changing priorities and requirements
+ Ability to perform computer operations, such as ability to navigate in MS Office and complete Computer Based Training (CBT)
+ Ability and willingness to work any shift in support of operations, which may include the occasional night or weekend shift, as required.
+ Ability to handle first tier problem solving that may involve cross functional interactions
+ Pass eye exam (corrected or uncorrected) in order to be qualified to perform visual inspection of raw materials. Failing these disqualifies a staff member from performing essential activities for the role.
+ Color Vision: Normal via Ishihara testing methods.
+ Stereo Depth Perception: (corrected or uncorrected) Stereo Depth less than or equal to 100 Arc Seconds.
+ Near Vision: (corrected or uncorrected) of 20/20, both eyes together.
Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Vast opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**Apply now**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
**Equal Opportunity Statement**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Job title: Quality Assurance Operational Support

• Location: Tuas, Singapore

• Hiring Manager: Manager, Quality Operations
   

About the Job

Sanofi is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges. Digital will be one of the key topics to help Modulus to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: “Sanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+”. 

In this context, we are looking for Specialist I, Quality Operations for our new site based in Singapore. 

Key Accountabilities  

• The mission described below, must be exercised in compliance with health, safety and environment of the site rules. 

• The Specialist I, Quality Operations will be responsible to partner with the GMP operations team to provide Quality oversight and advice for Quality on-the-floor and operations support to ensure the Tuas Singapore GMP Quality operations meets Sanofi global Quality standard requirements and fulfil the applicable regulatory expectations.

• The Specialist I, Quality Operations shall be experienced in solving problems, with a competent understanding of cGMP operations and well-versed in multiple Quality systems (including electronic batch record exception management, deviations/CAPAs and document management system). 

• The incumbent will partner closely with operational teams (e.g. manufacturing, facilities, Quality control and technical units) to ensure quality, safety, reliability, efficiencies to support Modulus Singapore GMP manufacturing operations.

During the Project Phase, the Specialist I, Quality Operations will participate in the following:
 

1) Engineering / Commissioning & Qualification activities

• Review and approval of engineering documents related to GMP operations. 

• Review and approval of operational, as well as process related documents (e.g. work instructions, SOPs, batch records). 

• Ensure that Quality related operational procedures and infrastructures are successfully implemented in preparation for Engineering runs and PPQ runs at the Tuas Singapore Site to support site operational readiness and success. 
   

2) Provide GMP Quality support during PPQ runs

• Responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies. 

• Responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials and Drug Substance Intermediate release, deviations, change controls and CAPAs) at Tuas Singapore manufacturing facility. 

• Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations. 

• Escalate significant Quality issues to Quality management in a timely manner. 

• Champion Quality within the Operations team to establish an engrained Quality culture across the organization. 
   

3) Working hours

• Personnel shall be able to work office hours (weekdays) in Sanofi Site Office to support collaborations and meetings with stakeholders leading up to Engineering runs. 

• Personnel shall be able to work 12 hours rotating shift (including day/night, and weekends) on site to support PPQ runs and Engineering runs, as required. 

During Routine Operations, the Specialist I, Quality Operations shall: 

• Be responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies. 

• Be accountable to ensure that Quality related operational procedures and infrastructures are successfully implemented to support Modulus Singapore site operational and inspection readiness and success. 

• Be responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials release, deviations, change controls and CAPAs) at Tuas Singapore manufacturing facility. 

• Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations. 

• Escalate significant Quality issues to Quality management in a timely manner. 

• Champion Quality within the Operations team to establish an engrained Quality culture across the organization. 

• Lead and support the site driven QA continuous improvement initiatives/activities during the routine operational phase.

2) Working hours

• Personnel must be able to work 12 hours rotating shift (including day/night, and weekends) on site to support production activities. 

About You

• Bachelor’s or Master’s Degree in Sciences, engineering or other related technical field. 

• Minimum of 2 to 5 years of relevant experiences preferably in Manufacturing, Validation, Engineering, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics). 

• Manufacturing 4.0 mindset (such as Agile methodology) and process technical knowledge. 

• Basic understanding of QA Operations (from an end-to-end perspective). 

• Strong interpersonal skills to establish the partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse. 

• Ability to work independently and make quick, effective decisions under pressure. 

• Familiarity with electronic batch record (MES) and related review processes. 

• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and execution levels. 

•  Experience in facility start-ups will be advantageous. 

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Take good care of your

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
About the role:
The Associate Director Quality Operations is responsible for ensuring the quality of processes and product outputs. This role involves defining activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and customer quality standards. By maintaining high-quality standards, this role supports Takeda's mission to bring better health to people and a brighter future to the world.
How you will contribute:
* Define and specify activities, processes, and standards to fulfill quality requirements
* Audit, monitor, and determine the quality of processes or outputs against defined standards
* Conduct product integrity testing to ensure compliance with quality requirements
* Report on process deviations and defects
* Manage and lead teams and projects, ensuring operational success
* Influence organizational goals and maintain frequent communication with peers and customers
* Tackle complex problems and meet budgets and schedules
Skills and qualifications:
* Independently implements Corrective And Preventive Action strategies in routine and moderately complex situations, identifying flaws and formulating preventive measures with minimal guidance.
* Conducts audits independently in routine and moderately complex situations, with a comprehensive understanding of auditing principles and minimal guidance.
* Applies safety assurance practices independently in routine and moderately complex situations with minimal guidance.
* Conducts investigations in routine and moderately complex scenarios, applying key techniques with minimal guidance.
* Applies Quality Management Systems independently in routine and moderately complex situations, with a comprehensive understanding of key concepts and minimal guidance needed.
* Executes Quality Assurance principles independently in routine and moderately complex situations with minimal guidance.
* Executes change control procedures for routine and moderately complex changes with minimal guidance.
* Utilizes advanced decision-making skills to complex situations, provides recommendations, and mentors others in decision-making processes.
* Manages tasks requiring high attention to detail, independently addresses complex scenarios, and advises others on maintaining precision.
* Applies Continuous Improvement Process principles in routine and moderately complex situations with minimal guidance, showing a comprehensive understanding of the concepts and methodologies.
* Carries out routine and moderately complex tasks in manufacturing operations, with a comprehensive understanding of production processes.
* Writes independently across routine and some complex scenarios with a good grasp of grammar, punctuation, and structure, requiring minimal guidance.
As a leader of a functional area or organization, you will set objectives, delegate tasks, and ensure operational success, with reviews by senior management. You will also help shape company policies, tackle complex problems, and meet budgets and schedules. Your responsibilities include managing projects, influencing organizational goals, maintaining frequent communication with peers and customers, and leading teams and projects, serving as a best practice/quality resource.
**Locations**
SGP - Singapore - Woodlands
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time

For our Client-a prestigious and well-established Biopharmaceutical Company developing diverse portfolio of therapies worldwide-we are currently looking for an experienced Quality Assurance Associate to join Parexel FSP on a full-time permanent contract.
Offering competitive salary with an excellent benefits package-we would like to bring on board a dedicated Individual with passion for clinical research.
The successful applicant will be a Registered Pharmacist and have good knowledge of GDP
**Mission**
+ Support the implementation and maintenance of the CHC Affiliate Quality System (covering GxP and health-regulated activities) across the local CHC Commercial organization, to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable GxP regulatory requirements.
+ Support the secure delivery of safe, efficient, quality CHC products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities.
+ Support the CHC CQH and Responsible Person, ensure GDP compliance of wholesale distribution activities within the CHC affiliate marketplace.
+ Serve as the secondary license holder for Company's importer and wholesaler licenses
**Tasks**
+ GxP and health-regulated activities related to the development, manufacturing, distribution and commercialization of all CHC drug and non-drug products contained in the CHC Affiliate portfolio
+ Collaboration and support to other CHC Affiliate GxP and health regulated Functions (Regulatory Affairs, Medical, Pharmacovigilance, Clinical, Supply Chain, etc.) and partnership with Business Functions across the CHC Affiliate
**Scope of Responsibility**
As CHC Affiliate Quality Assurance Associate:
- Support the CQH to define, implement, manage and control the CHC Affiliate Quality system across the CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements.
- CHC Affiliate Quality Documentation Management System :
o Organize within the CHC Affiliate a consistent management of Quality Documents related to GxP and health-regulated activities.
o Ensure screening process is implemented on released CHC Global Quality Documents and local regulations to capture the requirements that must be transcribed into CHC Affiliate Quality Documents.
o Provide guidance to CHC Affiliate Functions to develop or update local Quality Documents and related training modules in their respective domains.
- CHC Affiliate GxP regulatory inspections:
o Support to manage CHC Affiliate regulatory inspections related to GxP processes owned by the CHC Affiliate Country Quality Head and provide support to and coordination to other GxP Affiliate Functions in country regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level (as needed).
o Where applicable and required by local regulations and/or expectations of the local Regulatory Authorities, in coordination with CHC Affiliate Regulatory Affairs, support the Health Authorities in their inspections of foreign manufacturing sites.
- Support the CQH to act as the contact for GxP quality system audits performed by CHC Global Quality Audits (GQA) within the CHC Affiliate, and support CHC GQA in their audits preparation, conduct and follow-up.
- Support the CQH to implement a strategy for local audits based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by the CHC Affiliate; assure the coordination of the execution of the audits managed at CHC Affiliate level.
- Training: Ensure appropriate training to quality basics/quality matters of the CHC Affiliate personnel.
- Support the CQH to carry out an annual CHC Affiliate Country Quality Review, including quality oversight on activities executed by CHC Affiliate GxP and health-regulated Functions, and monitor the progress status of the defined Affiliate Quality program actions.
- Ensure implementation across the CHC Affiliate a process to manage deviations & CAPAs related to all GxP and health-regulated activities (including those related to audits & inspection observations) and ensure appropriate training of the affiliate personnel in scope.
- Support the CHC Affiliate process to manage the changes that may impact GxP or health-regulated process or operations by involving in multidisciplinary exchanges, implementing risk assessment and action plans when necessary.
- Monitor and periodically report CHC Affiliate Quality KPIs defined by CHC Global Quality (and any other additional relevant local quality indicators).
- Ensure that valid and signed Quality agreements (with the CHC Affiliate as Contract Giver) are in place (with internal CHC manufacturing sites, distribution centers, and/or External Manufacturing hubs, CMOs, distributors), for all GDP/GMP activities under the responsibility of Quality within the CHC Affiliate organization; ensure that quality-related clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities for CHC Affiliate.
- Support to ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved on selection process, qualification and performance of audits) or through coordination with the concerned CHC Affiliate Functions, as appropriate.
- Ensure that quality risks are properly managed across the CHC Affiliate
- Escalate and manage the quality events occurring within the CHC Affiliate according to defined processes and standards.
- Ensure the availability of up-to-date administrative records (e.g. CV, Job Description, Training log) for CHC Affiliate Quality positions as well as CHC Affiliate up-to-date organization charts; provide guidance to CHC Affiliate GxP and health-regulated Functions to be compliant with this requirement.
- Maintain an up-to-date local inventory of GxP computerized systems and GxP spreadsheets in use within the CHC Affiliate for GxP and health-regulated activities, and guarantee they are validated by the relevant ITS functions in charge.
- Manage CHC products quality complaints received by the CHC Affiliate and perform trend analysis.
- Support CQH to lead and coordinate CHC product batch recalls and ensure prompt execution of recall operations in coordination with other Functions within the CHC Affiliate, as per CHC Global Quality recall process.
- Ensure quality oversight on management of CHC product distribution issues including temperature excursions.
- Where applicable (as per local regulatory requirements):
o Perform local Market Batch Release/Disposition
o Ensure quality oversight on local distributors ("Buy & sell CHC products" partners)
o Support to manage notifications from and to local Health Authorities for CHC product related quality events in liaison with other CHC Affiliate Functions as appropriate
- As CHC Affiliate Quality Business Partner, foster quality culture across the CHC Affiliate, interact closely with CHC Affiliate stakeholders to provide appropriate quality input and agile support to local CHC business and CHC e-commerce business.
- Support CQH to manage CHC Affiliate Quality budget.
- Be the backup for other countries' CQHs (as applicable) during his/ her absence as mutually agreed (as applicable) to perform critical Quality tasks or manage quality related notifications or alerts.
+ Support for other assigned tasks and projects by line manager as applicable.
As CHC Affiliate GDP/Wholesale Distribution Secondary License Holder:
Ensure that all the Importing and Wholesale distribution activities covered by the corresponding Importer and Wholesale Distribution License are operated by the CHC Affiliate in full compliance with GDP requirements.
The responsibilities of the Importer and Wholesale Distribution secondary license holder are the following:
- Ensure obtaining the GDP/WDL license and maintain it up to date
- Ensure that a Quality Management System has been implemented and is maintained
- Focus on the management of authorized activities and the accuracy and quality of records
- Ensure that initial and continuous training programs are implemented and maintained
- Coordinate and promptly perform any recall operations for CHC products
- Ensure that relevant customer complaints occurring in the distribution channels are dealt with effectively
- Decide on the final disposition of returned, rejected, recalled or falsified CHC products
- Approve any returns to saleable stock
- Ensure that processes are in place in order to handle out of stock situations and associated communication to relevant parties, in coordination with other CHC Affiliate Functions (e.g. Regulatory Affairs, Supply Chain, Medical)
- Ensure that suppliers and customers are approved
- Ensure that CHC products are being distributed only to validated customers
- Approve any subcontracted activities which may impact on GDP
- Keep appropriate records of any delegated duties
- Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
- Ensure that any additional requirements imposed on certain CHC products by Singapore territory law are adhered.
+ Where required, be the primary license holder during interim period of CQH transition (as applicable).
Support for Regulatory Administrative in Health Authority's system
- Support regulatory administration submission for applications through health authority system or local government applications.
**Management Responsibilities :**
The role holder has a direct reporting to ASEA Zone Quality Head (also CQH of Opella Singapore).
**Latitude of Action :**
The role holder is required to work in line with CHC Global Quality Policy, Standards and Processes.
**Role Impact :**
lt is a key role in ensuring consistent application of Quality requirements across the CHC Affiliate.
**Scope :**
It works together with CHC Affiliate GxP functions such as Medical Affairs, Regulatory Affairs, Pharmacovigilance and Supply Chain as well as with colleagues from other Quality operational units as required.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Company Overview

Our client is looking for a Quality Assurance Engineer/Japanese Language specialist to join their team. QA Engineers will be the ones to maintain high quality and user experience across its digital channels, including e-commerce sites, mobile apps.

Job Description

• Conduct linguistic, functional, visual, accessibility, and device testing for assigned projects to ensure all aspects of digital products meet the highest standards.
• Integrate aspects of Quality Assurance, including test creation and execution, defect management, and collaboration with key stakeholders.
• Resolve tickets based on established priority and follow the protocol for updating the tickets to the proper state when work is performed.

Qualifications

• 2+ years' experience with relevant field (Quality Assurance, Software Tester, Software Engineer etc)
• Good to have experience working in QA for website/mobile or desktop applications.
• Business level fluency in Japanese, with excellent writing skills for high-quality linguistic testing and communication with stakeholders.

Preferred:

• Proven experience in using and developing automated test capabilities.
• Understanding of API and experience using API tools for testing.

JAC Recruitment Pte. Ltd.

EA License Number: 90C3026

EA Personnel: R1985155

Rui Watanabe

**THE FUTURE IS WHAT WE MAKE IT.**
**_Senior Advanced Quality Assurance Engineer_**
**_Changi, Singapore_**
Start your career by making an impact and real connections with some of the most meaningful challenges around. When you join Honeywell, you become a member of our performance culture comprised of diverse leaders, thinkers, innovators, dreamers, and doers who are changing the future.
**Make the Best You.**
Working at Honeywell is not just creating incredible things. You will collaborate with top minds, grow through continuous learning, and benefit from an inclusive environment that rewards performance and celebrate achievements.
**Join Us and Make an Impact.**
Quality team provides Validation towards all new feature development, with automation frameworks and also enables the Development teams to enable them to test and deploy their changes across environments with focus on Shift-Left Quality. Products to be worked on include Core Azure cloud services.
In this role you will be part of a team of software engineers responsible for the Quality of new products developed, using the test framework for use by HCE Connected Building development teams to build large scale cloud platform offerings and services.
At Honeywell, our approach is simple. We hire talented people, nurture their growth, give them opportunities to make a difference, and promote from within.
**Key Responsibilities:**
+ Expected to validate/ verify product through manual testing and automated testing
+ Expected to understand the product requirement and define the test strategy and test plan
+ Expected to report the defects in Jira Tool and track the defects resolution
+ Expected to oversee the customer deployment and provide technical support
+ 4 to 6 years of experience in Buildings (Energy, Sustainability, Zero carbon footprint, HVAC BMS) domain, Product testing
+ Strong knowledge of Buildings protocols like BACnet, Modbus, Lonworks and DDC controllers and understanding of Sustainability, Zero Emissions standards, LEED standard
+ Enjoy problem solving and attention to detail
+ Team player and can work with global teams
+ Strong customer focus. The ability to partner with senior level management and business stakeholders, to understand HCE Connected Buildings businesses/functions, and to deliver the best global design/deployment solutions.
+ Self-motivated, goal oriented, determine own work priorities, training requirements, ability to meet deadlines and works well under pressure.
+ Learns quickly adapting to new projects, technologies, processes and/or cross industry verticals.
**Key Experience & Capabilities:**
+ Masters/Bachelors Degree in information systems, Information Technology, Software Engineering or Computer Science.
+ ISTQB Test Professional Certification (preferred)
+ Have done end -to -end product testing
+ 4 to 6 years of experience in Buildings (Energy, Sustainability, Zero carbon footprint, HVAC BMS) domain, Product testing
+ Strong knowledge of Buildings protocols like BACnet, Modbus, Lonworks and DDC controllers and understanding of Sustainability, Zero Emissions standards, LEED standards
+ Experience with test tools is a good-to-have
+ Deep understanding of Building controls, commissioning experience is preferred
+ Understanding of controller functioning, DDC testing and troubleshooting is required
+ Skills on cloud environment programming & automation, Azure and OpenShift experience is preferred.
+ Knowledge of Azure services, hands-on experience with testing Azure services / Docker hosted applications
+ Advanced Understanding of Networking Concepts (TCP / IP Stack, Firewalls, S2S VPN)
**Who We Are**
The Future Is What We Make It at Honeywell. From sustainable aviation fuel and life-saving healthcare sensors to collaborating on every NASA space mission since the 1950's, over 100 years of innovation has always been driven by an investment in our people. Learn more about Honeywell: More**
Our focus at Honeywell is innovation that drives business, improves the bottom line and creates solutions for our customers and communities around the world. There's a lot for you to discover. Our solutions, our case studies, our #Futureshapers, and so much more.
Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.
For more information on how we process your information in the job application process, please refer to honeywell.com/us/en/privacy-statement .
If a disability prevents you from applying for a job through our website, e-mail No other requests will be acknowledged.
**Copyright © 2024 Honeywell International Inc.**
Honeywell helps organizations solve the world's most complex challenges in automation, the future of aviation and energy transition. As a trusted partner, we provide actionable solutions and innovation through our Aerospace Technologies, Building Automation, Energy and Sustainability Solutions, and Industrial Automation business segments - powered by our Honeywell Forge software - that help make the world smarter, safer and more sustainable.
Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Quality Assurance Manager (Quality Responsible Person at market) for Australia and New Zealand, will work collaboratively with relevant stakeholders to implement & maintain the local Australian and New Zealand Quality Management System (QMS) and will work with internal & external stakeholders to ensure quality requirements are met for Gilead products, throughout the distribution network, and within Australia and New Zealand, all the way to patients.
**Key Responsibilities:**
+ Establishes and maintains the QMS in Australia and New Zealand to ensure that it meets local regulatory and industry standards and Gilead expectations.
+ Support maintenance of relevant licenses.
+ Manages local process of change control, deviation, CAPA, complaint management and supplier management.
+ Manages local Quality Management Review process.
+ Manages local Risk Assessment/Management for any quality-related risks.
+ Participates in Gilead's Quality Escalation process for critical quality issues, and regulatory compliance issues.
+ Ensures up to date organograms, training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for local affiliate personnel working on quality/distribution matters.
+ Establishes and maintains the Affiliate Quality Manual and GMP/GDP procedural documents.
+ Establishes and maintains the Quality Agreement with 3PL/4PL and local GMP/GDP related suppliers/service providers, as required.
+ Reviews Annual Product Quality Reports (if applicable)
+ Ensures shipping conditions match the product license/product label particulars and transporters are appropriately qualified.
+ Ensures premises and/or equipment used are reviewed regularly to ensure they are adequate to allow the handling, storage, and distribution of medicinal products in a manner that ensures the maintenance of product quality.
+ Supports Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.
+ Working with 3PL/4PL, provides guidance on supply related issues.
+ Arranges authorized relabeling/repackaging in cooperation with 3PL/4PL (where applicable)
+ Supports the management of quality and distribution complaints.
+ Supports the investigation of fraudulent and counterfeit medicinal products.
+ Manages product return and destruction.
+ Manages local recalls and participating in supplier's recall challenge or perform local mock recall, as needed.
+ Qualifies and manages local 3PL/4PL and supports audit of 3PL/4PL.
+ Qualifies and manages local GMP/GDP related suppliers/service providers, auditing and approving these according to local requirements.
+ Assure customers validations and adequate records compliance to Gilead QA requirements are established and maintained for all local distributors/customers.
+ Host and lead Health Authority inspections and corporate audits.
+ Manages the Affiliate self-inspection program.
+ Supports audit of distributor (where applicable).
+ Collaborates with RA to implement activities for new product launch and product life cycle management.
**Knowledge, Experience & Skills:**
+ Highly organized individual with a strong work ethic and ability to work flexibility and independently.
+ Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs) and knowledgeable about the specific requirements for Australia and New Zealand.
+ Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
+ Demonstrates proficiency in Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.)
+ Demonstrates a knowledge of regional/local regulatory requirements and industry standards.
+ Demonstrates strong verbal, written, and interpersonal skills in English.
+ Demonstrates proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP ERP, etc.
+ Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.
**Typical Educational Experience & Competencies**
+ Bachelors' degree and 7+ years of relevant experience in a GMP or GDP environment-related field (pharmaceutical or pharma-related)
+ Masters' degree and 5+ years of relevant experience in a GMP or GDP environment related field (pharmaceutical or pharma-related)
+ Ability to work on own initiative as well as display strong teamwork skills.
+ Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed. '
+ Ability to support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Pall Corporation, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety and environmentally responsible technologies. From airplane engines to hydraulic systems, scotch to smartphones, OLED screens to paper-everyday Pall is there, helping protect critical operating assets, improve product quality, minimize emissions and waste, and safeguard health. For the exponentially curious, Pall is a place where you can thrive and amplify your impact on the world. Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation.
Learn about the Danaher Business System ( which makes everything possible.
Are you a person who enjoys making positive, tangible changes that improve the overall quality of a product or process? Do you have a passion for leading quality systems and processes? Are you customer oriented? If so, then maybe you would be a great fit for our Director Quality Director Quality Assurance - Microelectronics/APAC.
This position is part of the Quality and Regulatory Affairs department and is an onsite position.
In this role, you will have the opportunity to:
+ Develop positive relationships with Key Customers, OPS team and Commercial Leaders
+ Develop and implement Micro Electronics Industry leading quality systems and processes to support customer needs and expectations.
+ Establish and handle QA tracking and trending of crucial performance measures (DPPM) and the preparation of periodic reports for management review.
+ Implement and maintain an effective quality management system for Micro-E specific plants and aligned to corporate and BU policies, procedures, and industry specific requirements.
The essential requirements of the job include
+ University Degree in mechanical/electrical or chemical engineering with a minimum of 10 years of dynamic quality assurance experience, with at least 5 years at senior level with multi-site and multi-region experience
+ Thorough understanding of ISO 9001 standard. GMP knowledge and other ISO standards required.
+ Fully conversant with AIAG Core tools, APQP, statistical analysis and the principles of variation reduction.
#onsite #LI-VH
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

**Manager QA (Plant Quality Assurance)**
**Amgen Singapore Manufacturing**
**HOW MIGHT YOU DEFY IMAGINATION?**
Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a **Manager QA (Plant Quality Assurance- Shift)** in **Amgen Singapore Manufacturing** .
**Live**
**What you will do**
**Responsibilities:**
+ Responsible for providing oversight and leadership for Quality on-the-floor and operations support, the Manager Quality Assurance will support manufacturing operations and IPC testing through purposeful presence on the floor, and batch record closure, change controls, and unexpected result investigations. This role will be required to support shift work.
+ Provide direct Quality Assurance support for all GMP activities (including on-the-floor quality oversight, batch record closures, deviations closure, change control and CAPAs) at ASM
+ Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
+ Perform comprehensive Quality review to support lot disposition of bulk drug substance
+ Act as one of the key Quality Contacts to resolve complex issues, adhering to Amgen policies and standards
+ Participate in root cause investigations for complex and significant nonconformances, leveraging various root cause analysis tools
+ Develop best teams by ensuring that all team members are motivated to work toward common goals and coaching key talents.
+ Mentor and coach cross functional team members to establish a quality culture for routine operations
+ Develops a continuous improvement framework within the team, identifies and implements projects and improvements, actively supports site improvement programs to increase efficiency, agility, compliance, productivity, and also reduce cycle time, inventory and waste
+ Participate in regulatory inspections, and interact directly with regulatory inspectors
+ Escalate significant quality issues to Quality management in a timely manner
**Win**
**What we expect of you**
**Qualifications**
+ Doctorate degree OR
+ Master's degree and 2 years of directly related experience OR
+ Bachelor's degree and 4 years of directly related experience OR
+ Diploma and 8 years of directly related experience
+ Preferred 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems. Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.
+ Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
+ Experience with regulatory audits and inspections
+ Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
+ Supervisory experience will be an advantage
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Vast opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.**
**Apply now**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
**Equal Opportunity Statement**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.