GSK
pharmaceutical
Senior/QCSpecialistProjects(2YearContract)
“Senior / QC Specialist - Projects (2-Year Contract) at GSK. Skills: Quality Control, method validation, analytical methods. Lead method validation. Perform testing for project activities”
What You'll Achieve.
Ensure all aspects of QC testing are completed; Ensure test method validation is completed; Ensure analytical equipment qualification is completed; Ensure analytical method transfer is completed; Ensure laboratory and analytical capacity are completed; Ensure local QC unit participates in method development and validation; Ensure local QC unit is ready to transit into lifecycle management; Ensure compliance to applicable corporate, regulatory and external agency regulations; Ensure timely implementation of the projects with full compliance; Ensure project maximizes the use of digitalization, automation and robotics; Ensure spendings are within project target budget; Adhere to test release and project plan; Ensure policies and SEHSS are deployed and respected; Ensure methods/ knowledge are effectively transferred to routine testing team
Industry & Context.
laboratory investigations
2-Year Contract
What They're Looking For.
Must Have
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
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 activities
Provide expertise on QC matters
Ensure timely project implementation
Keep up-to-date on regulations
Develop and endorse plans
Collaborate on test method innovation
Write/review GMP documents
Ensure spendings within budget
Perform testing for adherence
Respect safety and security policies
Plan and execute transition
Knowledge management on retention
How You'll Work.
Team & Collaboration
Collaborates with globalelgium QC; Collaborates with global Manufacturing Science and Technology (MSAT); Works closely with global/local QC stakeholders; Collaborates closely with global and Belgium QC departments
Communication Scope
Good written and verbal communication skills in English
Process & Methodology
Project Management, method validation, method development, method verification, method transfer, equipment introduction, compliance to regulations, cost management, training plan, facility design, project target budget
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