1,099 Quality Lead jobs in Singapore

Engineering Quality Lead

Singapore, Singapore ANOTECH ENERGY SINGAPORE PTE. LTD.

Posted today

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Job Description

Roles & Responsibilities

ALTEN Group is a world leader in Engineering and Technology consulting services providing outsourced Engineering, R&D, and IT Services for different industries such as Transportation, Defence, Energy and Security with 55,000 engineers in nearly 35 countries. ANOTECH is the subsidiary of the Group delivering ALTEN's Engineering Services in Singapore.

As an Engineering Quality Leader, you will ensure the implementation of processes, practices and specific tools, to make sure quality on product development is in line with the tailored processes as well as the technical requirements and international regulations (ISO, ASPICE, etc.) for the embedded projects.

Responsibilities:


• Manage compliance to Quality Assurance and Customer requirements and their flow down to the Engineering Team


• Define and apply the Quality Management System and relevant Quality Plan specific for the development project (HW and SW)


• Assure the quality of solutions in collaboration with Solution or Software Engineering Managers by participation to FAT, or inspection


• Assure that Anomalies, Non-conformities and Alerts are followed and closed through the managed Non-Conformities process


• Support the Certifications (ISO 9001, CMMI, ASPICE and ACSMS for process adherence)


• Collaborate with the Solution or Software Engineering Manager to establish the Certificate of Conformity


• Exercise Alert Duty and Veto Right in case of non-resolution of problems and escalate it to the correspondent management organization, manage and capitalize on alerts and vetoes


• Complies with auditing plan and conduct audits to the projects then follow up the Non-Conformity raised in the Audit until closure out


• Ensure that all processes are well known to the Engineering Team and its stakeholders by providing and deploying Engineering and


• Project process training


• Collect, maintain and monitor the KPIs for technical debt for Engineering Teams


• Facilitate the Postmortem session for all projects and monitor the actions of improvements until its closure


• Ensure that the solution developed (HW and SW) is complying with both customer and company requirements with the required and expected level of Quality


• Support the development teams in identifying and resolving problems, assuring that the relevant processes, practices and applicable standards and regulations have been followed


• Analyze the data resulting from audits, return and customer complaints, alert and veto right, to prevent the risks


• Approve or make sure of the formal approval of the conformity of products and to be in charge of the follow-up of the complaints from the customers


• Contribute as required to project reviews supplying feedback by using the quality advices


• Support and verify tailoring activities of Thales practices and their result in the relevant existing documentation


• Support and verify the process implementation applicable at development level (HW and SW) with internal audits and/or follow-up


• Support the ISO 9001 and ASPICE certifications as well as the ACSMS adherence

Essential Requirements:


• Tertiary qualification in Engineering or technical disciplines or equivalent (Electronic is preferential)


• At least 5 years of Quality Assurance activities or senior experience in similar positions.


• Experience in Quality in Engineering/Development teams (preferable within Electronics/Telecommunication context)


• Process Analysis, Improvement and Deployment.


• Knowledge of Quality Plan/ Quality Inspection & Test Plan


• Knowledge of Quality Standards like ISO 9001, CMMI, ASPICE and ACSMS


• Knowledge of AGILE at SCALE (SW, HW, SYSTEM Integration)


• Strong time management, organizational, interpersonal and communication skills


• Result & customer oriented, critical thinking, flexibility and high capacity to work within multicultural teams


• Ability to speak fluently in English


• Knowledge on IT and Engineering tools like Microsoft Office, Jira, Confluence, etc.


• It will be considered a plus if you possess the following knowledge:

Ø IVVQ Strategy

Ø Standardization (Configuration Management mindset)

Ø Project Management

Tell employers what skills you have

CMMI
Test Equipment
Quality Management
Quality Assurance
Quality System
Critical Thinking
ISO
System Integration
Agile
Risk Management
Auditing
Quality Inspection
ISO 9001
Engineering Design
Automotive Industry
Design Control
Training Leadership
Product Development
Audit
Quality Audits
This advertiser has chosen not to accept applicants from your region.

Engineering Quality Lead

Singapore, Singapore ANOTECH ENERGY SINGAPORE PTE. LTD.

Posted today

Job Viewed

Tap Again To Close

Job Description

ALTEN Group is a world leader in Engineering and Technology consulting services providing outsourced Engineering, R&D, and IT Services for different industries such as Transportation, Defence, Energy and Security with 55,000 engineers in nearly 35 countries. ANOTECH is the subsidiary of the Group delivering ALTEN's Engineering Services in Singapore.
As an Engineering Quality Leader, you will ensure the implementation of processes, practices and specific tools, to make sure quality on product development is in line with the tailored processes as well as the technical requirements and international regulations (ISO, ASPICE, etc.) for the embedded projects.
Responsibilities:

• Manage compliance to Quality Assurance and Customer requirements and their flow down to the Engineering Team

• Define and apply the Quality Management System and relevant Quality Plan specific for the development project (HW and SW)

• Assure the quality of solutions in collaboration with Solution or Software Engineering Managers by participation to FAT, or inspection

• Assure that Anomalies, Non-conformities and Alerts are followed and closed through the managed Non-Conformities process

• Support the Certifications (ISO 9001, CMMI, ASPICE and ACSMS for process adherence)

• Collaborate with the Solution or Software Engineering Manager to establish the Certificate of Conformity

• Exercise Alert Duty and Veto Right in case of non-resolution of problems and escalate it to the correspondent management organization, manage and capitalize on alerts and vetoes

• Complies with auditing plan and conduct audits to the projects then follow up the Non-Conformity raised in the Audit until closure out

• Ensure that all processes are well known to the Engineering Team and its stakeholders by providing and deploying Engineering and

• Project process training

• Collect, maintain and monitor the KPIs for technical debt for Engineering Teams

• Facilitate the Postmortem session for all projects and monitor the actions of improvements until its closure

• Ensure that the solution developed (HW and SW) is complying with both customer and company requirements with the required and expected level of Quality

• Support the development teams in identifying and resolving problems, assuring that the relevant processes, practices and applicable standards and regulations have been followed

• Analyze the data resulting from audits, return and customer complaints, alert and veto right, to prevent the risks

• Approve or make sure of the formal approval of the conformity of products and to be in charge of the follow-up of the complaints from the customers

• Contribute as required to project reviews supplying feedback by using the quality advices

• Support and verify tailoring activities of Thales practices and their result in the relevant existing documentation

• Support and verify the process implementation applicable at development level (HW and SW) with internal audits and/or follow-up

• Support the ISO 9001 and ASPICE certifications as well as the ACSMS adherence
Essential Requirements:

• Tertiary qualification in Engineering or technical disciplines or equivalent (Electronic is preferential)

• At least 5 years of Quality Assurance activities or senior experience in similar positions .

• Experience in Quality in Engineering/Development teams (preferable within Electronics/Telecommunication context)

• Process Analysis, Improvement and Deployment.

• Knowledge of Quality Plan/ Quality Inspection & Test Plan

• Knowledge of Quality Standards like ISO 9001, CMMI, ASPICE and ACSMS

• Knowledge of AGILE at SCALE (SW, HW, SYSTEM Integration)

• Strong time management, organizational, interpersonal and communication skills

• Result & customer oriented, critical thinking, flexibility and high capacity to work within multicultural teams

• Ability to speak fluently in English

• Knowledge on IT and Engineering tools like Microsoft Office, Jira, Confluence, etc.

• It will be considered a plus if you possess the following knowledge:
Ø IVVQ Strategy
Ø Standardization (Configuration Management mindset)
Ø Project Management
This advertiser has chosen not to accept applicants from your region.

Production Quality Lead Position

Singapore, Singapore beBeeQuality

Posted today

Job Viewed

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Job Description

Job Title

Quality Assurance Manager Role

The Quality Assurance Manager oversees the organization's quality control activities, ensuring all products meet standards.

  • Supervise inspections and documentation by inspectors, collecting and filing required Quality Records.
  • Prepare and review Quality records for customers as needed.
  • Control customer drawings, including updating drawing revisions.
  • Prepare Quality checklists and inspection criteria.
  • Manage in-house and supplier quality.
  • Evaluate inspector qualifications.
  • Plan and manage internal and external audits.
  • Administer and improve the ISO Quality System.
  • Maintain documents and supervise equipment calibration management activities.
  • Ensure Safety - Risk Assessment preparation and review.
  • Perform ad-hoc tasks as requested.
Requirements
  • Diploma/GCE 'O' Level or equivalent with 1-2 years QC experience / relevant experience on usage of measurement instruments and experience in Quality Certification.
  • Excellent use of Excel, Word, Power Point, Outlook, Acrobat, and Windows.
  • Experience with First Article Process is highly advantageous.
  • Blue print reading knowledge and manufacturing experience is a must.
  • Knowledge of ISO 9001:2008.
  • Ability to converse in Mandarin to communicate with our China office.
  • Ability to commence work immediately or short notice will be an advantage.
Benefits
  • Medical benefit.
  • Annual Leave.
  • Bonus.
  • Work Life Balance.
  • Good working environment.
This advertiser has chosen not to accept applicants from your region.

Engineering Quality Lead - Automotive Spice

088541 $10000 Monthly ANOTECH ENERGY SINGAPORE PTE. LTD.

Posted 6 days ago

Job Viewed

Tap Again To Close

Job Description

ALTEN Group is a world leader in Engineering and Technology consulting services providing outsourced Engineering, R&D, and IT Services for different industries such as Transportation, Defence, Energy and Security with 55,000 engineers in nearly 35 countries. ANOTECH is the subsidiary of the Group delivering ALTEN's Engineering Services in Singapore.


As an Engineering Quality Leader, you will ensure the implementation of processes, practices and specific tools, to make sure quality on product development is in line with the tailored processes as well as the technical requirements and international regulations (ISO, ASPICE, etc.) for the embedded projects.


Responsibilities:

• Manage compliance to Quality Assurance and Customer requirements and their flow down to the Engineering Team

• Define and apply the Quality Management System and relevant Quality Plan specific for the development project (HW and SW)

• Assure the quality of solutions in collaboration with Solution or Software Engineering Managers by participation to FAT, or inspection

• Assure that Anomalies, Non-conformities and Alerts are followed and closed through the managed Non-Conformities process

• Support the Certifications (ISO 9001, CMMI, ASPICE and ACSMS for process adherence)

• Collaborate with the Solution or Software Engineering Manager to establish the Certificate of Conformity

• Exercise Alert Duty and Veto Right in case of non-resolution of problems and escalate it to the correspondent management organization, manage and capitalize on alerts and vetoes

• Complies with auditing plan and conduct audits to the projects then follow up the Non-Conformity raised in the Audit until closure out

• Ensure that all processes are well known to the Engineering Team and its stakeholders by providing and deploying Engineering and

• Project process training

• Collect, maintain and monitor the KPIs for technical debt for Engineering Teams

• Facilitate the Postmortem session for all projects and monitor the actions of improvements until its closure

• Ensure that the solution developed (HW and SW) is complying with both customer and company requirements with the required and expected level of Quality

• Support the development teams in identifying and resolving problems, assuring that the relevant processes, practices and applicable standards and regulations have been followed

• Analyze the data resulting from audits, return and customer complaints, alert and veto right, to prevent the risks

• Approve or make sure of the formal approval of the conformity of products and to be in charge of the follow-up of the complaints from the customers

• Contribute as required to project reviews supplying feedback by using the quality advices

• Support and verify tailoring activities of Thales practices and their result in the relevant existing documentation

• Support and verify the process implementation applicable at development level (HW and SW) with internal audits and/or follow-up

• Support the ISO 9001 and ASPICE certifications as well as the ACSMS adherence


Essential Requirements:

• Tertiary qualification in Engineering or technical disciplines or equivalent (Electronic is preferential)

At least 5 years of Quality Assurance activities or senior experience in similar positions .

Experience in Quality in Engineering/Development teams (preferable within Electronics/Telecommunication context)

• Process Analysis, Improvement and Deployment.

• Knowledge of Quality Plan/ Quality Inspection & Test Plan

• Knowledge of Quality Standards like ISO 9001, CMMI, ASPICE and ACSMS

• Knowledge of AGILE at SCALE (SW, HW, SYSTEM Integration)

• Strong time management, organizational, interpersonal and communication skills

• Result & customer oriented, critical thinking, flexibility and high capacity to work within multicultural teams

• Ability to speak fluently in English

• Knowledge on IT and Engineering tools like Microsoft Office, Jira, Confluence, etc.

• It will be considered a plus if you possess the following knowledge:

Ø IVVQ Strategy

Ø Standardization (Configuration Management mindset)

Ø Project Management

This advertiser has chosen not to accept applicants from your region.

Quality Control Lead

Singapore, Singapore LUMENS PTE. LTD.

Posted 12 days ago

Job Viewed

Tap Again To Close

Job Description

About Us

Founded in 2014, Lumens Group is leading the transformation of the mobility industry in Singapore. We have successfully built one of Singapore's largest car fleets and expanded our offerings to personal and corporate leasing, purchasing and financing. As we enter a new phase, we're building an integrated ecosystem for merchants and consumers, driven by advanced technology and a mission to enrich everyday life.

Your Role on Our Journey

  • Diagnose and troubleshoot issues with vehicles using computerized diagnostic equipment and conduct road tests.
  • Able to perform corrective and preventative maintenance tasks such as oil changes, tire rotations, and brake pad replacements.
  • Repair and replace faulty parts, including engines, transmissions, brakes, and suspension systems.
  • Conduct Quality Assurance inspections to identify potential problems and recommend necessary repairs to ensure road worthiness.
  • Provide accurate estimates and approving of repair quotations from partnering workshops.
  • Keeping records of repairs, maintenance and issues pertaining to fleet.
  • Stay up-to-date with manufacturer updates, technical bulletins, and industry developments.
  • Communicate with the respective departments on the identified issues of the respective vendors and come out with a resolution.
  • Able to identify spare parts by looking at parts diagram for spares ordering.

Requirements:

  • Need to have a valid driving license of more than 2 years
  • Able to work during weekends as required (5.5 day work week)
  • Need to have vehicle related knowledge and familiarity with various vehicle makes and models.
  • Strong problem-solving and analytical skills
  • Good communication and customer service skills.

Ready to Drive the Extra Mile?

Send your resume that showcases your unique spark to us today. If your journey aligns with ours, we'll get in touch soon!

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Quality Control Lead

Singapore, Singapore CELLVEC PTE. LTD.

Posted 12 days ago

Job Viewed

Tap Again To Close

Job Description

Job responsibilities:

Responsible for the operational aspects of all analytical testing within the QC Laboratory.

  • Lead, coach and develop QC personnel (analysts and scientists) to ensuring that analytical testing (chemical, physical and microbiological) and data review is performed in a reliable and timely manner to support production operations with adherence to Standard Operating Procedures (SOP).
  • Ensure that the quality systems and practices in the laboratory comply with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP) and Quality Management Standards (QMS).
  • Develop, optimize, implement analytical methods and working procedures for characterization, release, and stability testing of viral vector gene therapy products.
  • Develop the organisation's quality testing policy in alignment with regulatory standards.
  • Lead and perform lab method validation, transfers of analytical methods from other collaborators/clients, protocol harmonization and optimization from R&D to Production.
  • Lead development and qualification of new and/or improved assays and characterization of viral vector products using molecular, biophysical, and other analytical assays.
  • Conduct, review or approve laboratory investigations and ensure all follow up actions are completed. Make decisions based on scientific and logical reasoning.
  • Compile data, generate reports and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.
  • Align with MSAT, Quality and Production teams on phase appropriate analytical methods and strategies for in-process and QC release testing.
  • Collaborate with team members to identify and evaluate assay improvements with the goal of optimizing the current rAAV production process.
  • Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operations.
  • Draft and edit lab protocols, standard operating procedures, sampling plans, technical documents, and release testing records for regulatory or tech transfer purposes.
  • Ensure real time documentation, maintain data integrity and appropriate traceability as per quality system.

Qualifications:

  • PhD in Cell and Molecular Biology, Immunology, Biotechnology, Biochemistry, Microbiology or related fields with 6+ years of relevant experience, or Master/Bachelor’s degree with a minimum of 8+ years of relevant industry experience in a cGMP setup.
  • Prior experience performing viral genome titre, infectivity, potency, host cell protein, and host cell DNA assays are required.
  • Extensive hands-on experience with development of analytical techniques for characterization and analysis of viral vectors is desired, including: Flow cytometry, qPCR, dPCR, ELISA, SDS-PAGE, Western blot, mycoplasma, sterility, endotoxins.
  • Experience in the design and optimization of cell-based potency and infectivity assays.
  • Must have experience facing regulatory, Client & external cGMP audits.
  • Must have the knowledge of contract testing labs management and its certification.
  • Strong knowledge of Regulatory and Pharmacopeia requirements for viral vector gene therapy products.
  • Experience with processes involved in viral vector GMP manufacturing, characterization and QC release testing.
  • A highly motivated team player with an ability to be productive and a willingness to lead and learn in a fluid, fast-paced and environment are essential.
  • Excellent organizational and collaborative skills.
#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Quality Control Lead

Singapore, Singapore CELLVEC PTE. LTD.

Posted today

Job Viewed

Tap Again To Close

Job Description

Job responsibilities:

Responsible for the operational aspects of all analytical testing within the QC Laboratory.

  • Lead, coach and develop QC personnel (analysts and scientists) to ensuring that analytical testing (chemical, physical and microbiological) and data review is performed in a reliable and timely manner to support production operations with adherence to Standard Operating Procedures (SOP).
  • Ensure that the quality systems and practices in the laboratory comply with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP) and Quality Management Standards (QMS).
  • Develop, optimize, implement analytical methods and working procedures for characterization, release, and stability testing of viral vector gene therapy products.
  • Develop the organisation's quality testing policy in alignment with regulatory standards.
  • Lead and perform lab method validation, transfers of analytical methods from other collaborators/clients, protocol harmonization and optimization from R&D to Production.
  • Lead development and qualification of new and/or improved assays and characterization of viral vector products using molecular, biophysical, and other analytical assays.
  • Conduct, review or approve laboratory investigations and ensure all follow up actions are completed. Make decisions based on scientific and logical reasoning.
  • Compile data, generate reports and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.
  • Align with MSAT, Quality and Production teams on phase appropriate analytical methods and strategies for in-process and QC release testing.
  • Collaborate with team members to identify and evaluate assay improvements with the goal of optimizing the current rAAV production process.
  • Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operations.
  • Draft and edit lab protocols, standard operating procedures, sampling plans, technical documents, and release testing records for regulatory or tech transfer purposes.
  • Ensure real time documentation, maintain data integrity and appropriate traceability as per quality system.

Qualifications:

  • PhD in Cell and Molecular Biology, Immunology, Biotechnology, Biochemistry, Microbiology or related fields with 6+ years of relevant experience, or Master/Bachelor’s degree with a minimum of 8+ years of relevant industry experience in a cGMP setup.
  • Prior experience performing viral genome titre, infectivity, potency, host cell protein, and host cell DNA assays are required.
  • Extensive hands-on experience with development of analytical techniques for characterization and analysis of viral vectors is desired, including: Flow cytometry, qPCR, dPCR, ELISA, SDS-PAGE, Western blot, mycoplasma, sterility, endotoxins.
  • Experience in the design and optimization of cell-based potency and infectivity assays.
  • Must have experience facing regulatory, Client & external cGMP audits.
  • Must have the knowledge of contract testing labs management and its certification.
  • Strong knowledge of Regulatory and Pharmacopeia requirements for viral vector gene therapy products.
  • Experience with processes involved in viral vector GMP manufacturing, characterization and QC release testing.
  • A highly motivated team player with an ability to be productive and a willingness to lead and learn in a fluid, fast-paced and environment are essential.
  • Excellent organizational and collaborative skills.
#J-18808-Ljbffr

This advertiser has chosen not to accept applicants from your region.
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Quality Control Lead

Singapore, Singapore LUMENS PTE. LTD.

Posted today

Job Viewed

Tap Again To Close

Job Description

About Us

Founded in 2014, Lumens Group is leading the transformation of the mobility industry in Singapore. We have successfully built one of Singapore's largest car fleets and expanded our offerings to personal and corporate leasing, purchasing and financing. As we enter a new phase, we're building an integrated ecosystem for merchants and consumers, driven by advanced technology and a mission to enrich everyday life.

Your Role on Our Journey

  • Diagnose and troubleshoot issues with vehicles using computerized diagnostic equipment and conduct road tests.
  • Able to perform corrective and preventative maintenance tasks such as oil changes, tire rotations, and brake pad replacements.
  • Repair and replace faulty parts, including engines, transmissions, brakes, and suspension systems.
  • Conduct Quality Assurance inspections to identify potential problems and recommend necessary repairs to ensure road worthiness.
  • Provide accurate estimates and approving of repair quotations from partnering workshops.
  • Keeping records of repairs, maintenance and issues pertaining to fleet.
  • Stay up-to-date with manufacturer updates, technical bulletins, and industry developments.
  • Communicate with the respective departments on the identified issues of the respective vendors and come out with a resolution.
  • Able to identify spare parts by looking at parts diagram for spares ordering.

Requirements:

  • Need to have a valid driving license of more than 2 years
  • Able to work during weekends as required (5.5 day work week)
  • Need to have vehicle related knowledge and familiarity with various vehicle makes and models.
  • Strong problem-solving and analytical skills
  • Good communication and customer service skills.

Ready to Drive the Extra Mile?

Send your resume that showcases your unique spark to us today. If your journey aligns with ours, we'll get in touch soon!

#J-18808-Ljbffr

This advertiser has chosen not to accept applicants from your region.

Quality Control Lead

Singapore, Singapore LUMENS PTE. LTD.

Posted today

Job Viewed

Tap Again To Close

Job Description

Roles & Responsibilities

About Us

Founded in 2014, Lumens Group is leading the transformation of the mobility industry in Singapore. We have successfully built one of Singapore's largest car fleets and expanded our offerings to personal and corporate leasing, purchasing and financing. As we enter a new phase, we're building an integrated ecosystem for merchants and consumers, driven by advanced technology and a mission to enrich everyday life.

Your Role on Our Journey

  • Diagnose and troubleshoot issues with vehicles using computerized diagnostic equipment and conduct road tests.
  • Able to perform corrective and preventative maintenance tasks such as oil changes, tire rotations, and brake pad replacements.
  • Repair and replace faulty parts, including engines, transmissions, brakes, and suspension systems.
  • Conduct Quality Assurance inspections to identify potential problems and recommend necessary repairs to ensure road worthiness.
  • Provide accurate estimates and approving of repair quotations from partnering workshops.
  • Keeping records of repairs, maintenance and issues pertaining to fleet.
  • Stay up-to-date with manufacturer updates, technical bulletins, and industry developments.
  • Communicate with the respective departments on the identified issues of the respective vendors and come out with a resolution.
  • Able to identify spare parts by looking at parts diagram for spares ordering.

Requirements:

  • Need to have a valid driving license of more than 2 years
  • Able to work during weekends as required (5.5 day work week)
  • Need to have vehicle related knowledge and familiarity with various vehicle makes and models.
  • Strong problem-solving and analytical skills
  • Good communication and customer service skills.

Ready to Drive the Extra Mile?

Send your resume that showcases your unique spark to us today. If your journey aligns with ours, we'll get in touch soon

Tell employers what skills you have

Customer Service Skills
Quality Control
Analytical Skills
Quality Assurance
ISO
GMP
Purchasing
Mobility
Estimates
Vehicles
Raw Materials
Driving License
Audits
Laboratory
Manufacturing
Calibration
This advertiser has chosen not to accept applicants from your region.

Quality Control Lead

118518 $8000 Monthly CELLVEC PTE. LTD.

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

Job responsibilities:

Responsible for the operational aspects of all analytical testing within the QC Laboratory.

  • Lead, coach and develop QC personnel (analysts and scientists) to ensuring that analytical testing (chemical, physical and microbiological) and data review is performed in a reliable and timely manner to support production operations with adherence to Standard Operating Procedures (SOP).
  • Ensure that the quality systems and practices in the laboratory comply with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP) and Quality Management Standards (QMS).
  • Develop, optimize, implement analytical methods and working procedures for characterization, release, and stability testing of viral vector gene therapy products.
  • Develop the organisation's quality testing policy in alignment with regulatory standards.
  • Lead and perform lab method validation, transfers of analytical methods from other collaborators/clients, protocol harmonization and optimization from R&D to Production.
  • Lead development and qualification of new and/or improved assays and characterization of viral vector products using molecular, biophysical, and other analytical assays.
  • Conduct, review or approve laboratory investigations and ensure all follow up actions are completed. Make decisions based on scientific and logical reasoning.
  • Compile data, generate reports and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.
  • Align with MSAT, Quality and Production teams on phase appropriate analytical methods and strategies for in-process and QC release testing.
  • Collaborate with team members to identify and evaluate assay improvements with the goal of optimizing the current rAAV production process.
  • Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operations.
  • Draft and edit lab protocols, standard operating procedures, sampling plans, technical documents, and release testing records for regulatory or tech transfer purposes.
  • Ensure real time documentation, maintain data integrity and appropriate traceability as per quality system.

Qualifications:

  • PhD in Cell and Molecular Biology, Immunology, Biotechnology, Biochemistry, Microbiology or related fields with 6+ years of relevant experience, or Master/Bachelor’s degree with a minimum of 8+ years of relevant industry experience in a cGMP setup.
  • Prior experience performing viral genome titre, infectivity, potency, host cell protein, and host cell DNA assays are required.
  • Extensive hands-on experience with development of analytical techniques for characterization and analysis of viral vectors is desired, including: Flow cytometry, qPCR, dPCR, ELISA, SDS-PAGE, Western blot, mycoplasma, sterility, endotoxins.
  • Experience in the design and optimization of cell-based potency and infectivity assays.
  • Must have experience facing regulatory, Client & external cGMP audits.
  • Must have the knowledge of contract testing labs management and its certification.
  • Strong knowledge of Regulatory and Pharmacopeia requirements for viral vector gene therapy products.
  • Experience with processes involved in viral vector GMP manufacturing, characterization and QC release testing.
  • A highly motivated team player with an ability to be productive and a willingness to lead and learn in a fluid, fast-paced and environment are essential.
  • Excellent organizational and collaborative skills.
This advertiser has chosen not to accept applicants from your region.
 

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