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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
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Responsibilities:

• Overall in charge of quality control operations

• Plan work schedules for quality control department.

. Meet daily production schedule and performance expectations set up by Production Manager

• Provide immediate supervision, assign tasks, check works at frequent intervals, and maintain schedules

• Enforcing manufacturing system, procedures and policies

• Implementing and executing inspection, testing, and evaluation methods to ensure that products adhere closely to company standards.

• Identify & resolve technical and operational issues as well as identify potential issues and work with all team to implement proactive measures to accomplish operational objective within the own dept

. Implement and maintain the Quality Management Systems(ISO , ISO , AS9100, ISO45001(OSHA), Nadcap)

Requirements:

• 5 - 10 years or relevant work or industry experience

• Strong knowledge of quality control management

• Strong understanding of quality standards and health & safety regulations

• Strong decision-making skill with results-driven approach

• High level of discipline and integrity

• Willing to undertake multiple tasks

• Meticulous, keen attention to details and organized

. Hands-on experience with Quality Management Systems (QMS), inspection and testing methodologies.

This position focuses on ensuring quality across all project phases, from inspection to compliance. The ideal candidate will have a strong background in quality management and be able to effectively supervise and train team members.

Responsibilities:

· Overall in charge of quality control operations

· Plan work schedules for quality control department.

. Meet daily production schedule and performance expectations set up by Production Manager

· Provide immediate supervision, assign tasks, check works at frequent intervals, and maintain schedules

· Enforcing manufacturing system, procedures and policies

· Implementing and executing inspection, testing, and evaluation methods to ensure that products adhere closely to company standards.

· Identify & resolve technical and operational issues as well as identify potential issues and work with all team to implement proactive measures to accomplish operational objective within the own dept

. Implement and maintain the Quality Management Systems(ISO , ISO , AS9100, ISO45001(OSHA), Nadcap)

Requirements:

· 5 - 10 years or relevant work or industry experience

· Strong knowledge of quality control management

· Strong understanding of quality standards and health & safety regulations

· Strong decision-making skill with results-driven approach

· High level of discipline and integrity

· Willing to undertake multiple tasks

· Meticulous, keen attention to details and organized

. Hands-on experience with Quality Management Systems (QMS), inspection and testing methodologies.

Job Purpose

Lead and manage the company's QA/QC system across all EPC/EPCM projects to ensure full compliance with project specifications, client requirements, codes, and regulatory standards while fostering a strong quality culture.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) aligned with ISO standards and project requirements.
• Prepare and review Project Quality Plans, ITPs, method statements, and QA/QC procedures .
• Lead internal and external quality audits , including subcontractor and supplier assessments.
• Manage and oversee inspections and testing activities across projects.
• Lead NCR management, root cause analysis, corrective and preventive actions .
• Prepare and present quality performance reports and KPIs to management and clients.
• Conduct quality training and awareness programs for project teams.
• Liaise with clients, consultants, and regulatory bodies on all QA/QC matters.
• Drive continuous improvement initiatives to enhance quality performance.

Qualifications & Experience

• Degree in Mechanical, Electrical, Civil Engineering, or Quality Management.
• 10+ years of QA/QC experience in EPC/EPCM or construction, with 3+ years in a managerial role.
• ISO 9001 Lead Auditor certification preferred.
• Experience with BCA CONQUAS/QM implementation.

Core Competencies

• Strong leadership and team management skills.
• In-depth knowledge of QA/QC codes, standards, and processes.
• Excellent communication, report writing, and analytical skills.

Requirements:
Recognized Degree in related field
Experience in working with Contractors
Relevant experience in Civil/ Building, preferably with experience in facade installation works
Good team player and adaptable to dynamic environment
Responsibilities:
Responsible for effective implementation of overall project quality management system (QMS).
Preparation of relevant reports for recommendation and continuously improvements for the project.
Responsible for managing team of QA/QC engineers.
Preparation and compilation of Inspection and Test Plan (ITP), Project Quality Plan (PQP) and Operation Maintenance and Manual (OMM).
Ensure the requirements of Project Quality Plan/Manual is implemented and adhered to the assigned project.
Liaise with Clients' and Sub-Contractors' Quality representatives.
Participate in audits by Clients' team of the Company's systems implemented on assigned Projects.
Investigate and document and resolve any Clients' complaints about Quality.
Make recommendations to Project team regarding improvements on Quality.
Assist Project and QA/QC Team in inspection and testing as necessary.
Liaise with Independent Inspection and Testing Agency in respect of factory and Site inspections in line with Project Specification requirements.
Maintaining, improving and implementing Project Quality system and Quality plans in conjunction with the project team.
Investigation of Quality deficiencies and implementation of corrective action as well as recommendation for preventive actions.
Identify and document Quality problems, seek solutions and verify the implementation of solutions.
Any other duties as directed by Managing Director
Checking that all non-conforming materials, components and equipment are promptly identified and segregated pending their final disposition.
Liaise with RE/RTO and all other parties in respect of inspection and handing over of installed steel and facade elements.
Perform inspection and check for all quality related procedures.
Coordinate with the managers and supervisors of the projects.
Responsible for closure of Non-conformance reports and Site Instruction.
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Job Purpose

Lead and manage the company’s QA/QC system across all EPC/EPCM projects to ensure full compliance with project specifications, client requirements, codes, and regulatory standards while fostering a strong quality culture.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) aligned with ISO standards and project requirements.
• Prepare and review Project Quality Plans, ITPs, method statements, and QA/QC procedures .
• Lead internal and external quality audits , including subcontractor and supplier assessments.
• Manage and oversee inspections and testing activities across projects.
• Lead NCR management, root cause analysis, corrective and preventive actions .
• Prepare and present quality performance reports and KPIs to management and clients.
• Conduct quality training and awareness programs for project teams.
• Liaise with clients, consultants, and regulatory bodies on all QA/QC matters.
• Drive continuous improvement initiatives to enhance quality performance.

Qualifications & Experience

• Degree in Mechanical, Electrical, Civil Engineering, or Quality Management.
• 10+ years of QA/QC experience in EPC/EPCM or construction, with 3+ years in a managerial role.
• ISO 9001 Lead Auditor certification preferred.
• Experience with BCA CONQUAS/QM implementation.

Core Competencies

• Strong leadership and team management skills.
• In-depth knowledge of QA/QC codes, standards, and processes.
• Excellent communication, report writing, and analytical skills.

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.

Apply now by submitting a Cover Letter and CV to

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.
Werkzaamheden
Je 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.

Jij herkent jezelf in de volgende eigenschappen:
- 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.

Sollicitatie
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.
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