QC Operations Specialist

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