QC Method Validation Lead for Biopharma Projects

gsk; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

GSK Tuas Vaccines in Singapore seeks a QC Specialist to support QC validation, method transfer and analytical testing for new projects. You will collaborate with global QC and MSAT teams to ensure readiness for lifecycle management and compliance with GMP and lab quality systems.

The role emphasizes project management in analytical validation, equipment qualification, and knowledge transfer, with hands-on testing and a focus on digitalization and automation in QC operations.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, microbiology, life sciences or a related discipline.
• Minimum 4 to 6 years’ experience in a QC or analytical laboratory, preferably in pharmaceutical or life sciences settings.
• Practical knowledge of GMP principles and laboratory quality systems.
• Hands-on experience with analytical methods and laboratory investigations.
• Experience coordinating method validation, verification or transfer activities.
• Good written and verbal communication skills in English.

Responsibilities

• Leads method validation, development, verification, transfer and new equipment introduction. Performs testing for project related activities as required.
• Provides expertise and consultation to projects team on technical QC matters to ensure compliance to applicable corporate, regulatory and external agency regulations.
• Ensures timely implementation of the projects with full compliance to corporate, regulatory and external agency regulations if applicable.
• Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.
• Collaborates closely with global QC networks on test method innovation/ evaluation to support the project team in facility design / modification, specifically for QC operations.
• Writes/ reviews change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports).
• Ensures spendings are within project target budget.
• Perform testing when required to adhere to test release and project plan
• Respects all safety and security polices, laboratory policies and practices on site and ensures policies and SEHSS are deployed and respected.
• Anticipate, plan and execute the transition from a project mode to routine mode in terms of QC operations.
• Knowledge management on knowledge retention and effective training to ensure methods/ knowledge are effectively transferred to routine testing team.

Skills

Data integrity

Detail-oriented

Digital fluency

GxP regulations

Quality assurance

Quality control

Testing operations

Risk awareness

Problem solving

Lean management

Education

Bachelor's degree in chemistry, biochemistry, microbiology, life sciences or related discipline

Job description

GSK Tuas Vaccines in Singapore seeks a QC Specialist to support QC validation, method transfer and analytical testing for new projects. You will collaborate with global QC and MSAT teams to ensure readiness for lifecycle management and compliance with GMP and lab quality systems.

The role emphasizes project management in analytical validation, equipment qualification, and knowledge transfer, with hands-on testing and a focus on digitalization and automation in QC operations.