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
Other Special Requirements A good understanding of the overall view of drug development process. A thorough understanding of the principles and management of cGMP compliance, and strong quality minds. C...