GSK
Pharmaceutical
Senior/QCSpecialist-Projects(2-YearContract)
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“Senior / QC Specialist - Projects (2-Year Contract) at GSK. Skills: Method validation, Method transfer, QC testing, GMP. Lead method validation, development, verification, transfer and new. Perform testing for project related activities”
Industry & Context.
Laboratory investigations
What They're Looking For.
Must Have
Bachelor's degree in chemistry, biochemistry, microbiology, life sciences or a related discipline, 4 to 6 years’ experience in a QC or analytical laboratory, 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
Nice to Have
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
What You'll Do.
Lead method validation
Perform testing for project related activities
Provide expertise and consultation to projects team on
Ensure compliance to applicable corporate
regulatory and external
Ensure timely implementation of the projects
Keep up-to-date on regulations/ development of biopharmaceutical QC
Ensure project maximizes use of digitalization
Develop and endorse analytical transfer plan
Develop and endorse validation master plan
Develop and endorse cost management
Develop and endorse training plan
Collaborate with global and Belgium QC departments on
Support project team in facility design / modification
Write change controls
Review change controls
Write events/ deviations
Review events/ deviations
Ensure spendings are within project target budget
Perform testing to adhere to test release and
Respect all safety and security polices
Respect laboratory policies and practices on site
Ensure policies and SEHSS are deployed and respected
plan and execute transition from project mode
Manage knowledge on knowledge retention
Ensure effective training for knowledge transfer
How You'll Work.
Team & Collaboration
Global QC; Global MSAT; Global/local QC stakeholders; Global and Belgium QC departments
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project Management
Full Job Description
To provide technical support to the projects team for Quality Control (QC) related activities for the new projects introduced in GSK Tuas Vaccines. He/she represents Tuas QC unit and collaborates with global/Belgium QC as well as global Manufacturing Science and Technology (MSAT) in all areas of QC validation and operation. The QC Specialist / Senior QC Specialist ensures that all aspects of QC testing of the new projects, test method validation, analytical equipment qualification, analytical method transfer, laboratory and analytical capacity are successfully completed. For new analytical test methods introduced, the QC Specialist / Senior QC Specialist ensures that the local QC unit participates in the method development and validation. He/ She will also support the local QC unit to be ready to transit into lifecycle management. **Responsibilities** This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Project Management * Leads method validation, development, verification, transfer and new equipment / technology 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. * Works closely with global/local QC stakeholders to develop and endorse the following: Analytical transfer plan, validation master plan, cost management (eg. facility, analytical equipment) and training plan * Collaborates closely with global and Belgium QC departments on test method innovation/ evaluation to support
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