Quality Control Manager
3 days ago
Work Location: Tuas Biomedical Park
Responsibilities:
Responsible for routine operation of QC lab, including but not limited to:
- Manage the routine operation of QC team to ensure the business delivery at the right quality, cost and speed.
- Management several sub-teams like product testing group, and microbial group
- Lead the team to comply with internal requirements in all aspects via end-to-end quality control system oversight
- Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement
- Provide support and technical directions for any technical/experiment work required during investigation and definition of corrective and preventive actions
- Oversight of the training, evaluation and management of the staff in QC lab. Coaching, developing and supporting them in reaching their full potential
- Responsible for the GMP audit from regulatory authorities and clients. Reply to audit reports and create CAPAs
Qualifications:
- Bachelor's degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related disciplines
- Minimum 7 years of experience in biotech or biopharma industry
- A good understanding of the overall view of the drug development process
- A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset
- Comprehensive knowledge of FDA, EMA, NMPA, ICH, WHO technical guidelines, and USP, Eur.P, ChP pharmacopoeias
- Comprehensive knowledge of IND/IMPD, NDA, and ANDA filing
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