Job Description:
- Lead projects for method validation, transfer, and verification.
- Author protocols and reports.
- Ensure compliance with industry standards.
- Maintain validated assay status.
- Qualify or re-qualify QC equipment.
- Troubleshoot equipment failures.
- Maintain validated equipment status.
- :Support QC method launches.
- Coordinate regulatory document changes.
- Author regulatory submission documents.
- Trend and investigate invalid assays.
- Serve as a subject matter expert.
- Lead investigations.
- :Identify improvements and troubleshoot assays.
- Drive harmonization and simplification.
- Prepare for audits and present findings.
Requirement
- Min Degree / Diploma in Science/ Chemical Engineer or other equivalent
- Experience in GMP
- Experience in QC equipment qualification such as writing protocol (preferred to have experience for TOC analyzer, microplate reader)
- Experience in performing control trending and critical material critical qualifications
- Experience in Labware and MODA
- Experience in QC System administration
- Basic knowledge on regulatory requirement on equipment qualification
- Strong Project Management skill
If interested, please email at [email protected]
➖
Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
