This is an IT support group | Quality Control Manager
12 hours 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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