Job Description:
- Able to lead project for Method validation/verification/transfer to introduce new/remediated QC methods for testing existing and new products independently
- Subject matter expert in method validation, verification and transfer; covering wide arrays of methods and complex techniques
- Author of Method validation/verification/transfer Protocols, Reports, Reports, ensuring GMP compliance in 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
- Ensure RFT in the method introduction process
- Maintain validated status of assays by establishing a control and monitoring strategy to ensure that the method is in the state of control, and the data generated from the method is reliable.
Requirement
- Min Degree / Diploma in Science/ Chemical Engineer or other equivalent
- Min experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.Six Sigma Greenbelt training would be helpful.
- Demonstrated experience e.g. in the area of method validation, method transfer, method verification, Unexpected Results investigation.
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)
