Description
We are seeking a QC Specialist / Senior QC Specialist to provide technical support to the projects team for Quality Control (QC) related activities for new projects introduced in GSK Tuas Vaccines.
The successful candidate will represent the Tuas QC unit and collaborate with global/Belgium QC as well as global Manufacturing Science and Technology (MSAT) in all areas of QC validation and operation.
Responsibilities
- Leads method validation, development, verification, transfer, and new equipment/technology introduction.
- Provides expertise and consultation to projects team on technical QC matters to ensure compliance with applicable corporate, regulatory, and external agency regulations.
- Ensures timely implementation of projects with full compliance to corporate, regulatory, and external agency regulations.
- Keeps up-to-date on regulations and developments in biopharmaceutical QC methods/technology.
- Collaborates with global/local QC stakeholders to develop and endorse analytical transfer plans, validation master plans, cost management, and training plans.
- Writes/reviews change controls, events/deviations, CAPAs, and GMP documents.
- Ensures spending is within project target budget.
- Performs testing when required.
- Respects all safety and security policies, laboratory policies, and practices on site.
QC Operation
- Anticipates, plans, and executes the transition from project mode to routine mode in terms of QC operations.
- Knowledge management on knowledge retention and effective training.
Basic Qualifications
- Bachelor's degree in chemistry, biochemistry, microbiology, life sciences, or a related discipline.
- Minimum 4-6 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.
Preferred Qualifications
- Advanced degree (MSc) in a relevant scientific discipline.
- Experience with chemistry, biochemistry, environmental monitoring, and water system testing.
- Experience with stability testing and stability data review processes.
- Familiarity with laboratory equipment qualification, calibration programs, and computerized systems.
- Experience supporting regulatory inspections as a subject matter expert.
- Experience leading or coaching small teams and driving continuous improvement.