1,726 Quality Manager jobs in Singapore
Quality Control Manager
Posted 8 days ago
Job Viewed
Job Description
Direct message the job poster from ESCO ASTER PTE LTD
Esco Lifesciences Group is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.
Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.
Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.
Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.
Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.
We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.
The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.
Join us as we redefine BioSolutions for One World and One Health for the current and future generations to come.
One World Biosolutions for One Health.
Who we’re looking for
- Ability to understand protocols, technical reports and technology transfer documents.
- Ability to understand standard operating procedures and other related documents.
- Able to commit to weekend work when needed, off in lieu will be given for work on public holidays.
- Repetitive motions due to certain laboratory techniques.
- Good Understanding of Aseptic Techniques.
- Work performed in a clean room environment wearing PPE.
- Ability to define problems, collect data, establish facts and draw conclusions.
- Ability to focus regardless of circumstances and stress induced pressure.
- Ability to take proactive approach.
- Meticulous and systematic.
- Commitment to continuous learning and staying updated with industry best practices.
- Have a strong focus on safety, quality and timeliness.
- Have strong critical thinking skills.
Job Responsibilities
Sample and QC Process Management:
- Ensure all QC sample management, testing, including process validation, cleaning, raw materials, stability samples, water samples, etc., are planned and executed on time.
- Prioritize and plan all testing activities to support processing schedules.
- Plan QC testing on a FIFO basis to eliminate backlog and meet internal QC KPIs.
- Plan work assignments for all QC analysts based on the production plan.
- Support future setup of central QC lab for all BioSolutions within Esco Aster.
Leadership and Team Management:
- Lead the implementation of the Laboratory Information Management System (LIMS).
- Lead Quality Control SOP implementation.
- Collaborate with the Analytical Development Team and manage QC Analytical, Microbiology Team to manage the revision and/or change control of QC documents as needed.
- Ensure new Analysts and Specialists are trained appropriately.
- Supervise, develop, engage, and motivate a young and driven team of QC Team Members.
- Manage the routine operations of the QC lab, ensuring business delivery at the right quality, cost, and speed.
- Able to build and lead across functional department consisting of different QC functions and supervisors / deputies / subject matter.
Operational Oversight:
- Oversee several sub-teams such as sample management, reference management, regulatory management, and QC instrument and equipment management.
- Lead the team to comply with internal requirements in all aspects through end-to-end quality control system oversight.
- Ensure all activities in the QC team are performed in compliance with cGMP, data integrity, and EHS requirements.
- Keep up to date with the latest trends in Quality Controls Tools.
Training and Development:
- Oversee the training, evaluation, and management of staff in the QC lab, including coaching, developing, and supporting them to reach their full potential.
Regulatory Compliance:
- Manage GMP audits from regulatory authorities and clients, respond to audit reports, and create CAPAs as applicable.
- Support analytical method transfer activities.
- Author and review OOS/OOT and Deviation investigations for approval, maintaining investigation records in accordance with company policies.
- Participate in Quality Risk Assessment Programs.
- Provide input and expertise on QC testing and practices for all departments.
- Serve as the QC representative for all customer and agency audits and support the audit of all 3rd party contract facilities.
- Oversee the management of Sample and Controlled Substance inventories.
- Provide technical support and advice on QC matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Developments.
- Work with Analytical Sciences and Technology (ASAT) to internal or external tech transfer from developed protocols from Analytical Development to Quality control including overseeing method verification, qualification, and validation activities.
Compliance Management:
- Participate in self-inspection and support client audits.
- Manage compliance tasks to ensure the Quality Control department is current and compliant.
- Maintain purchase orders, cost centers, and budgets for the QC department.
- Manage implementation and adherence to all applicable SHE and cGMP regulations.
- Support and oversee 3rd party test labs and ensure test labs are qualified per our QMS.
- Perform calibration and maintenance of QC laboratory equipment working with our CMMS and as per Iso 17025 standards and relevant GLP standards.
- Support/ oversee QC laboratory equipment/system qualification.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor and Management from time to time to support GMP activities.
Requirements
- Bachelor’s degree in life sciences with minimum of 5 years of experience in Quality Control within highly regulated cGMP pharmaceutical industry. Experience is Biologics and ATMPs (i.e. Cell and Gene) is an added advantage.
- Candidates with experience in ATMPs (Cell & Gene) manufacturing are highly preferred but not mandatory.
- Familiar and keeping up to date with current GMP and applicable GxP regulations and standards; experience with regulatory requirements such as Singapore/HSA, US/FDA, EU/EMEA, etc.
- Good understanding of GMP requirements in release testing (Potency, Identity, Content, Impurities, Microbiological safety assays).
- Experience in HPLC, Flow Cytometry, ELISA, dPCR/PCR, Assays and method qualification.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Strong analytical skills and the ability to interpret data to drive decisions and improvements.
- Able to work independently, self- starter, self-motivated and task oriented.
- Good communication skills and leadership skills to effectively collaborate with cross-functional teams.
- A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset.
- Must be able to work in a team as well as independently.
- Proven leadership and team management skills.
- Excellent communication and organizational skills.
- Experience with LIMS and other laboratory management systems.
- Experience in Laboratory Equipment Qualification is an added advantage.
- Will be able to commit 5 working days per week in a fixed pattern.
- Apply now by submitting a Cover Letter and CV to
Apply now by submitting a Cover Letter and CV to
#J-18808-LjbffrQuality Control Manager
Posted today
Job Viewed
Job Description
Direct message the job poster from ESCO ASTER PTE LTD
Esco Lifesciences Group is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.
Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.
Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.
Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.
Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.
We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.
The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.
Join us as we redefine BioSolutions for One World and One Health for the current and future generations to come.
One World Biosolutions for One Health.
Who we’re looking for
- Ability to understand protocols, technical reports and technology transfer documents.
- Ability to understand standard operating procedures and other related documents.
- Able to commit to weekend work when needed, off in lieu will be given for work on public holidays.
- Repetitive motions due to certain laboratory techniques.
- Good Understanding of Aseptic Techniques.
- Work performed in a clean room environment wearing PPE.
- Ability to define problems, collect data, establish facts and draw conclusions.
- Ability to focus regardless of circumstances and stress induced pressure.
- Ability to take proactive approach.
- Meticulous and systematic.
- Commitment to continuous learning and staying updated with industry best practices.
- Have a strong focus on safety, quality and timeliness.
- Have strong critical thinking skills.
Job Responsibilities
Sample and QC Process Management:
- Ensure all QC sample management, testing, including process validation, cleaning, raw materials, stability samples, water samples, etc., are planned and executed on time.
- Prioritize and plan all testing activities to support processing schedules.
- Plan QC testing on a FIFO basis to eliminate backlog and meet internal QC KPIs.
- Plan work assignments for all QC analysts based on the production plan.
- Support future setup of central QC lab for all BioSolutions within Esco Aster.
Leadership and Team Management:
- Lead the implementation of the Laboratory Information Management System (LIMS).
- Lead Quality Control SOP implementation.
- Collaborate with the Analytical Development Team and manage QC Analytical, Microbiology Team to manage the revision and/or change control of QC documents as needed.
- Ensure new Analysts and Specialists are trained appropriately.
- Supervise, develop, engage, and motivate a young and driven team of QC Team Members.
- Manage the routine operations of the QC lab, ensuring business delivery at the right quality, cost, and speed.
- Able to build and lead across functional department consisting of different QC functions and supervisors / deputies / subject matter.
Operational Oversight:
- Oversee several sub-teams such as sample management, reference management, regulatory management, and QC instrument and equipment management.
- Lead the team to comply with internal requirements in all aspects through end-to-end quality control system oversight.
- Ensure all activities in the QC team are performed in compliance with cGMP, data integrity, and EHS requirements.
- Keep up to date with the latest trends in Quality Controls Tools.
Training and Development:
- Oversee the training, evaluation, and management of staff in the QC lab, including coaching, developing, and supporting them to reach their full potential.
Regulatory Compliance:
- Manage GMP audits from regulatory authorities and clients, respond to audit reports, and create CAPAs as applicable.
- Support analytical method transfer activities.
- Author and review OOS/OOT and Deviation investigations for approval, maintaining investigation records in accordance with company policies.
- Participate in Quality Risk Assessment Programs.
- Provide input and expertise on QC testing and practices for all departments.
- Serve as the QC representative for all customer and agency audits and support the audit of all 3rd party contract facilities.
- Oversee the management of Sample and Controlled Substance inventories.
- Provide technical support and advice on QC matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Developments.
- Work with Analytical Sciences and Technology (ASAT) to internal or external tech transfer from developed protocols from Analytical Development to Quality control including overseeing method verification, qualification, and validation activities.
Compliance Management:
- Participate in self-inspection and support client audits.
- Manage compliance tasks to ensure the Quality Control department is current and compliant.
- Maintain purchase orders, cost centers, and budgets for the QC department.
- Manage implementation and adherence to all applicable SHE and cGMP regulations.
- Support and oversee 3rd party test labs and ensure test labs are qualified per our QMS.
- Perform calibration and maintenance of QC laboratory equipment working with our CMMS and as per Iso 17025 standards and relevant GLP standards.
- Support/ oversee QC laboratory equipment/system qualification.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor and Management from time to time to support GMP activities.
Requirements
- Bachelor’s degree in life sciences with minimum of 5 years of experience in Quality Control within highly regulated cGMP pharmaceutical industry. Experience is Biologics and ATMPs (i.e. Cell and Gene) is an added advantage.
- Candidates with experience in ATMPs (Cell & Gene) manufacturing are highly preferred but not mandatory.
- Familiar and keeping up to date with current GMP and applicable GxP regulations and standards; experience with regulatory requirements such as Singapore/HSA, US/FDA, EU/EMEA, etc.
- Good understanding of GMP requirements in release testing (Potency, Identity, Content, Impurities, Microbiological safety assays).
- Experience in HPLC, Flow Cytometry, ELISA, dPCR/PCR, Assays and method qualification.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Strong analytical skills and the ability to interpret data to drive decisions and improvements.
- Able to work independently, self- starter, self-motivated and task oriented.
- Good communication skills and leadership skills to effectively collaborate with cross-functional teams.
- A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset.
- Must be able to work in a team as well as independently.
- Proven leadership and team management skills.
- Excellent communication and organizational skills.
- Experience with LIMS and other laboratory management systems.
- Experience in Laboratory Equipment Qualification is an added advantage.
- Will be able to commit 5 working days per week in a fixed pattern.
- Apply now by submitting a Cover Letter and CV to
Apply now by submitting a Cover Letter and CV to
#J-18808-LjbffrProduct Quality Control Manager
Posted today
Job Viewed
Job Description
Quality Assurance Specialist Role
The goal of this position is to guarantee the quality of finished products by inspecting them thoroughly and identifying defects, non-conformities, and deviations from quality standards.
- This entails conducting detailed inspections of finished products, which are essential for ensuring product excellence.
- As a Quality Assurance Specialist, you will support quality in handling defective parts and collaborate with the quality control team to resolve material quality issues.
- You will work closely with production and quality teams to identify root causes of defects and propose process improvements.
Conduct thorough examinations of finished products to identify defects, non-conformities, and deviations from quality standards.
2. Handle Defective PartsSupport quality in handling defective parts and collaborate with the quality control team to resolve material quality issues.
3. Collaborate on Quality IssuesWork with production and quality teams to identify root causes of defects and propose process improvements.
4. Interpret 2D DrawingsInterpret 2D drawings as part of your duties as a Quality Assurance Specialist.
We are looking for someone who can provide high-quality assurance through their attention to detail and ability to conduct thorough inspections. The ideal candidate should have relevant experience and be able to use measuring equipment effectively. If you are a detail-oriented individual with excellent communication skills, we encourage you to apply for this role.
Manufacturing Quality Control Manager
Posted today
Job Viewed
Job Description
Job Summary
">- Manage a team of quality control inspectors to guarantee product compliance with industry standards.
Key Responsibilities:
">- Lead the implementation and maintenance of quality control policies across production lines.
- Oversee sampling, inspections, and measurement procedures to ensure product quality.
- Collaborate with the production team to resolve quality issues promptly.
- Maintain detailed records and generate reports on quality findings for management review.
Requirements:
">- A minimum of 1-2 years of experience in manufacturing quality control.
- Familiarity with quality control tools and equipment.
- Strong organizational skills with attention to detail and ability to meet deadlines.
Benefits:
">- A competitive salary package with opportunities for growth.
- A permanent role with stable working hours (5 days, Mon-Fri, 8am-5:30pm).
Contact Information:
">- Please submit your application by clicking the APPLY button or continue your job search to maximize your opportunities.
Laboratory Quality Control Manager
Posted today
Job Viewed
Job Description
QC Laboratory Supervisor Job Opportunity
This is a challenging and rewarding role for an experienced laboratory supervisor to lead a team of laboratory assistants in ensuring quality control and compliance with operating standards.
- Lead a team of laboratory assistants in checking, testing, and inspecting raw materials, goods in process, and finished products.
- Prioritize and assign tasks to ensure effective use of resources, meet work schedules and targets.
- Assist in classification of final product and reworked lots.
- Troubleshoot and investigate quality issues, implement improvements from analysis gap studies.
Key responsibilities include monitoring in-process samples, liaising with production teams for preventive and corrective actions, preparing activity and progression reports, and training lab assistants and shift technicians.
To be successful in this role, you will need to have a strong understanding of laboratory equipment, experience in manual testing, and the ability to supervise and lead a team.
The ideal candidate will have a diploma or degree in a chemical-related field, a minimum of 5 years' hands-on experience in laboratory testing, and excellent leadership skills.
Quality Assurance and Quality Control Manager
Posted today
Job Viewed
Job Description
Job Title: QAQC Manager
We are seeking a highly skilled Quality Assurance and Quality Control (QA/QC) Manager to join our team. As a QAQC Manager, you will be responsible for ensuring that all construction projects meet the required quality standards.
Key Responsibilities:- Provide support to the Project Manager for the development, implementation, review and revision of the Project Execution Plan (PEP) and Project Quality Plan.
- Report on quality-related matters to the Project Manager, including preparation of monthly summary reports.
- Prepare Inspection and Test Plans (ITPs).
- Compile and receive relevant Material certificates and test reports from Suppliers.
- Coordinate with relevant testing laboratories for Material Testing and witnessing.
- Compile and maintain quality records, such as Request for Inspection (RFI), and verify as necessary.
- Coordinate on-site quality assurance and control activities, such as receiving and ensuring the correct concrete grade and type is delivered to respective areas and structures, witness concrete sampling and slump tests with QPS (client-engaged supervision team).
- Conduct independent Quality Assurance checks.
- Report non-conformities to the Project Manager, perform analysis, identify root cause, and propose corrective actions.
- Maintain and control QA/QC practices on a daily basis with regular checks and inspections to ensure correct operation and implementation of procedures.
- Bachelor Degree/Diploma in Civil Engineering or relevant field from Built Environment discipline.
- Minimum 10 years of QA/QC experience in the construction industry.
- Good understanding of construction industry practices and standards.
- Meticulous, eye for details, and a good team player.
- Able to multi-task in a fast-paced and dynamic environment.
Quality Assurance and Quality Control Manager
Posted today
Job Viewed
Job Description
Job Title: QAQC Manager
We are seeking a highly skilled Quality Assurance and Quality Control (QA/QC) Manager to join our team. As a QAQC Manager, you will be responsible for ensuring that all construction projects meet the required quality standards.
Key Responsibilities:
- Provide support to the Project Manager for the development, implementation, review and revision of the Project Execution Plan (PEP) and Project Quality Plan.
- Report on quality-related matters to the Project Manager, including preparation of monthly summary reports.
- Prepare Inspection and Test Plans (ITPs).
- Compile and receive relevant Material certificates and test reports from Suppliers.
- Coordinate with relevant testing laboratories for Material Testing and witnessing.
- Compile and maintain quality records, such as Request for Inspection (RFI), and verify as necessary.
- Coordinate on-site quality assurance and control activities, such as receiving and ensuring the correct concrete grade and type is delivered to respective areas and structures, witness concrete sampling and slump tests with QPS (client-engaged supervision team).
- Conduct independent Quality Assurance checks.
- Report non-conformities to the Project Manager, perform analysis, identify root cause, and propose corrective actions.
- Maintain and control QA/QC practices on a daily basis with regular checks and inspections to ensure correct operation and implementation of procedures.
Requirements:
- Bachelor Degree/Diploma in Civil Engineering or relevant field from Built Environment discipline.
- Minimum 10 years of QA/QC experience in the construction industry.
- Good understanding of construction industry practices and standards.
- Meticulous, eye for details, and a good team player.
- Able to multi-task in a fast-paced and dynamic environment.
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Quality Control manager (40 uur)
Posted 18 days ago
Job Viewed
Job Description
In Hoofddorp is het hoofdkantoor van Amazing Oriental gevestigd. Vanuit deze locatie diverse afdelingen operationeel waaronder Marketing, Inkoop, Finance, Logistiek en HR. Wij zijn voor het hoofdkantoor te Hoofddorp op zoek naar een Quality Control manager (QC). Je bent onderdeel van het team Quality Control.
Dit bieden wij jou- een marktconform salaris, 8% vakantiegeld en vakantiedagen (24 dagen op fulltime basis);
- personeelskorting in de winkel;
- een pensioenregeling (vanaf 18 jaar);
- verschillende doorgroei- en ontwikkelmogelijkheden.
Als QC-manager ben je verantwoordelijk voor het waarborgen van de kwaliteit en veiligheid van de voedingsproducten die door het bedrijf worden verhandeld. Dit omvat het ontwikkelen, implementeren en handhaven van kwaliteitscontroleprocessen en -systemen, het naleven van wettelijke en branchevoorschriften, en het bevorderen van een kwaliteitsbewuste cultuur binnen de organisatie.
WerkzaamhedenJe gaat de volgende werkzaamheden doen:
- Aansturing van het QC-team;
- Voorbereiden en begeleiden van ISO 22000 certificering;
- Up-to-date blijven met wijzigingen in relevante wetgeving en normen;
- Zorgen voor naleving van wet- en regelgeving, zoals van ISO 22000 en etikettering;
- Beoordelen van leveranciers op kwaliteitsnormen;
- Identificeren en implementeren van kansen voor procesverbetering;
- Samenwerken met afdelingen om kwaliteitsverbeteringen door te voeren;
- Beheren en onderzoeken van ontvangen klachten;
- Coördineren van recalls en opvolgen van corrigerende maatregelen.
- Proactief, resultaatgericht, stressbestendig, hoge mate van integriteit en het vermogen om een team te motiveren en te leiden;
- Afgeronde opleiding op HBO-niveau, met een bachelor- of masterdiploma in voedingsmiddelentechnologie, biochemie of een verwante discipline;
- Uitstekende beheersing van de Nederlandse taal en goede beheersing van de Engelse taal in woord en geschrift;
- Bekend met de wet- en regelgeving binnen de voedingsmiddelenindustrie en kennis van ISO 22000, en andere relevante kwaliteits- en voedselveiligheidsnormen;
- Minimaal 3 jaar ervaring in een kwaliteitsmanagementrol binnen de voedingsmiddelenindustrie;
- Bij voorkeur fulltime beschikbaar.
Ben jij enthousiast geworden na het lezen van de vacature? Wacht dan niet langer en solliciteer direct via de button! Heb je nog vragen, neem dan contact op met onze contactpersoon voor de afdeling QC via .
Let op: interne kandidaten hebben bij gebleken geschiktheid, voorrang op externe kandidaten.
Met deze vacature willen wij zelf onze nieuwe collega’s werven. Dit is dan ook geen oproep voor acquisitie.
#J-18808-LjbffrProduct and Quality Control Manager
Posted today
Job Viewed
Job Description
Job Responsibilities
1. Product Planning and Development Management
- Conduct market research on industry trends and customer needs to define differentiated selling points. Collaborate with R&D teams to evaluate the feasibility of materials, processes, and performance, ensuring technical alignment with market positioning.
- Establish product development milestones (testing -> sampling -> mass production) and define key deliverables.
2. Customer Requirement Alignment
- Engage in in-depth communication with customers to clarify technical requirements, delivery standards, etc. Work with R&D teams to conduct feasibility analyses, ensuring alignment between customer expectations and technical capabilities.
- Maintain a customer requirement tracking system, providing regular updates to internal teams to ensure execution meets customer expectations.
3. Project Roadmap Development
- Formulate R&D project plans, define technical roadmaps, and collaborate with R&D teams to facilitate the transition from development to industrialization, ensuring scalable production.
4. Project Execution and Risk Control
- Monitor project progress and quality, identify potential risks (e.g., technical, supply chain), and develop mitigation strategies to ensure on-time delivery.
- Ensure compliance with industry regulations (e.g., environmental standards, safety requirements) and oversee compliance reviews and certification applications.
5. Quality Inspection System Establishment and Maintenance
- Lead the quality team in building a full-process quality inspection system, covering incoming material inspection, in-process inspection, and finished product inspection to ensure overall product yield meets customer requirements. Assign inspection tasks, ensuring team members possess the necessary skills and proficiency in testing equipment operation.
- Define testing frequency and methodologies for critical performance indicators. Supervise testing activities to ensure data accuracy and traceability.
- Lead root cause analysis for defective products and drive corrective actions across production and process teams.
- Oversee product certification processes, ensuring test data meets certification requirements.
6. Customer Maintenance and Business Closure
- Hold regular meetings with customers to explore long-term collaborations (e.g., strategic procurement agreements, joint R&D projects) and translate customer needs into product development metrics.
- Maintain customer profiles, documenting key data to improve products and services.
Requirements:
- Bachelor degree or above in related fields
- 3-5 years of experience in manufacturing product quality control management.
- Able to communicate with Mandarin speaking clients and vendors.
Quality Control Manager/Senior Specialist
Posted today
Job Viewed
Job Description
The Opportunity
Esco Lifesciences Group is Singapore's most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.
Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.
Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.
Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.
Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.
We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.
The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.
Join us as we redefine BioSolutions for One World and One Health for the current and future generations to come.
Esco Aster.
One World Biosolutions for One Health.
Who we're looking for
Physical/Mental Requirements/Work Environment
· Ability to understand protocols, technical reports and technology transfer documents.
· Ability to understand standard operating procedures and other related documents.
· Able to commit to weekend work when needed, off in lieu will be given for work on public holidays.
· Repetitive motions due to certain laboratory techniques.
· Good Understanding of Aseptic Techniques.
· Work performed in a clean room environment wearing PPE.
· Ability to define problems, collect data, establish facts and draw conclusions.
· Ability to focus regardless of circumstances and stress induced pressure.
· Ability to take proactive approach.
· Meticulous and systematic.
· Commitment to continuous learning and staying updated with industry best practices.
· Have a strong focus on safety, quality and timeliness.
· Have strong critical thinking skills.
Job Responsibilities
Sample and QC Process Management:
· Ensure all QC sample management, testing, including process validation, cleaning, raw materials, stability samples, water samples, etc., are planned and executed on time.
· Prioritize and plan all testing activities to support processing schedules.
· Plan QC testing on a FIFO basis to eliminate backlog and meet internal QC KPIs.
· Plan work assignments for all QC analysts based on the production plan.
· Support future setup of central QC lab for all BioSolutions within Esco Aster.
Leadership and Team Management:
· Lead the implementation of the Laboratory Information Management System (LIMS).
· Lead Quality Control SOP implementation.
· Collaborate with the Analytical Development Team and manage QC Analytical, Microbiology Team to manage the revision and/or change control of QC documents as needed.
· Ensure new Analysts and Specialists are trained appropriately.
· Supervise, develop, engage, and motivate a young and driven team of QC Team Members.
· Manage the routine operations of the QC lab, ensuring business delivery at the right quality, cost, and speed.
· Able to build and lead across functional department consisting of different QC functions and supervisors / deputies / subject matter.
Operational Oversight:
· Oversee several sub-teams such as sample management, reference management, regulatory management, and QC instrument and equipment management.
· Lead the team to comply with internal requirements in all aspects through end-to-end quality control system oversight.
· Ensure all activities in the QC team are performed in compliance with cGMP, data integrity, and EHS requirements.
· Keep up to date with the latest trends in Quality Controls Tools.
Training and Development:
· Oversee the training, evaluation, and management of staff in the QC lab, including coaching, developing, and supporting them to reach their full potential.
Regulatory Compliance:
· Manage GMP audits from regulatory authorities and clients, respond to audit reports, and create CAPAs as applicable.
· Support analytical method transfer activities.
· Author and review OOS/OOT and Deviation investigations for approval, maintaining investigation records in accordance with company policies.
Cross-Departmental Collaboration:
· Participate in Quality Risk Assessment Programs.
· Provide input and expertise on QC testing and practices for all departments.
· Serve as the QC representative for all customer and agency audits and support the audit of all 3rd party contract facilities.
· Oversee the management of Sample and Controlled Substance inventories.
· Provide technical support and advice on QC matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Developments.
· Work with Analytical Sciences and Technology (ASAT) to internal or external tech transfer from developed protocols from Analytical Development to Quality control including overseeing method verification, qualification, and validation activities.
Compliance Management:
· Participate in self-inspection and support client audits.
· Manage compliance tasks to ensure the Quality Control department is current and compliant.
· Maintain purchase orders, cost centers, and budgets for the QC department.
· Manage implementation and adherence to all applicable SHE and cGMP regulations.
· Support and oversee 3rd party test labs and ensure test labs are qualified per our QMS.
· Perform calibration and maintenance of QC laboratory equipment working with our CMMS and as per Iso 17025 standards and relevant GLP standards.
· Support/ oversee QC laboratory equipment/system qualification.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor and Management from time to time to support GMP activities.
Requirements
· Bachelor's degree in life sciences with minimum of 5 years of experience in Quality Control within highly regulated cGMP pharmaceutical industry. Experience is Biologics and ATMPs (i.e. Cell and Gene) is an added advantage.
· Candidates with experience in ATMPs (Cell & Gene) manufacturing are highly preferred but not mandatory.
· Familiar and keeping up to date with current GMP and applicable GxP regulations and standards; experience with regulatory requirements such as Singapore/HSA, US/FDA, EU/EMEA, etc.
· Good understanding of GMP requirements in release testing (Potency, Identity, Content, Impurities, Microbiological safety assays).
· Experience in HPLC, Flow Cytometry, ELISA, dPCR/PCR, Assays and method qualification.
· Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
· Strong analytical skills and the ability to interpret data to drive decisions and improvements.
· Able to work independently, self- starter, self-motivated and task oriented.
· Good communication skills and leadership skills to effectively collaborate with cross-functional teams.
· A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset.
· Must be able to work in a team as well as independently.
· Proven leadership and team management skills.
· Excellent communication and organizational skills.
· Experience with LIMS and other laboratory management systems.
· Experience in Laboratory Equipment Qualification is an added advantage.
· Will be able to commit 5 working days per week in a fixed pattern.
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Tell employers what skills you haveMES
Pharmaceutical Industry
CAPA
Microsoft Suites
cGMP Manufacturing
cGMP
Quality Control
Work Well Independently
Team Player
Life Sciences