Key Responsibilities
- Lead and drive continuous improvement of QC metrology qualification and computerized system qualification processes.
- Plan, organize, and ensure execution of instrument and pipette calibration programs and preventive maintenance activities; review and approve related records.
- Coordinate with equipment vendors and Facilities & Engineering (F&E) teams to schedule and execute instrument maintenance and repairs, and review associated documentation.
- Organize and ensure execution of periodic instrument review (PRE) programs, including documentation review and compliance assessment.
- Lead or coordinate the qualification of analytical instruments, equipment, and systems, ensuring completeness and compliance of qualification documentation.
- Lead or support validation of analytical instrument software, including but not limited to 32Karat, SoloVPE, and EndoScanV.
- Ensure analytical systems are properly managed and maintained throughout their lifecycle in accordance with established procedures, including user account management, system configuration, and audit trail oversight.
- Support departmentdriven projects and continuous improvement initiatives that promote operational efficiency and a highperformance culture.
- Provide metrology and systemrelated training to end users, functional teams, or departments as required.
- Develop and manage timelines for software implementation and validation activities.
- Perform additional duties as assigned by the supervisor.
Requirement :
- Bachelor's degree or above in Chemistry, Microbiology, Biochemistry, or a related scientific discipline.
- Relevant experience in Quality Control or a related GMPregulated environment, with depth and breadth appropriate to the role.
- Prior people or team management experience is required.
- Demonstrated proficiency in scientific and technical writing, including preparation and review of GMP documentation.
- Strong critical thinking, scientific reasoning, and problemsolving capabilities.
- Practical experience working in a Quality Control laboratory and/or a GMPcompliant environment.
- Working knowledge of computerized system regulatory requirements, including but not limited to 21 CFR Part 11 and EU GMP Annex 11.
- Experience with analytical instrument lifecycle activities, including qualification, calibration, preventive maintenance (PM), troubleshooting, and repair for equipment such as UPLC, HPLC, CE, and CIEF.
Experience in the following areas is considered advantageous:
- Operation of analytical instruments and execution of sample testing.
- Handling deviations, change controls, and supporting regulatory or internal audits.
- Use and administration of instrument and laboratory software systems such as LES, ELN, Cispro, Empower, SoftMax Pro, EndoScanV, LabX, and LIMS.
