Job Description
Responsibilities
- Management of test samples: In-process and release samples, environmental testing samples and drug substance and excipient samples
- Stability sample management.
- Regulatory retain sample management.
- Reference sample management
- Perform annual fixed asset review
- Provide audit support such as audit preparation and as SME for related areas
- Project Management
- Archival of QC Documentation
- Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement.
Requirements
- Bachelor's degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline
- 6 to 12 years working experience in biotech or biopharma
- Deep understanding of FDA, EMA, ICH related regulations
- Good command of spoken and written English
Oth...