Job Description:
- Lead projects for method validation, verification, and transfer to introduce new or remediated QC methods for testing existing and new products independently.
- Serve as a subject matter expert in method validation, verification, and transfer, covering a wide array of methods and complex techniques.
- Author method validation, verification, and transfer protocols and reports, ensuring GMP compliance with ICH Q2(R1), USP <1225>, USP <1226>, EU GMP Chapter 6, and WHO Annex.
- Ensure timely release of methods to support commercial production, manufacturing investigations, and product investigations.
- Maintain validated status of assays by establishing a control and monitoring strategy to ensure method reliability.
- Lead projects for analytical equipment qualification to qualify/re-qualify QC equipment for testing existing and new products independently.
- Provide technical advice to local QC in laboratory-related troubleshooting, e.g., lab equipment failure.
- Author equipment qualification documents as indicated in global procedures.
- Ensure timely release of equipment to support commercial production.
- Maintain validated status of equipment.
Requirement
- Min. Deg in Chemistry, Biochemistry, Biotechnology, or a related field.
- Minimum of 3-5 years of experience in a pharmaceutical, biopharmaceutical, or related manufacturing environment.
- Six Sigma Greenbelt training is a plus.
- Demonstrated experience in method validation, method transfer, method verification, and unexpected results investigation.
- Proven ability to collaborate with cross-functional or cross-site teams to achieve objectives.
If interested, please email at [email protected]
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
