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Work Location: Tuas Biomedical Park
Responsibilities:
Responsible for the routine operation of the QC lab, including but not limited to the following:
- Managing the routine operation of the QC team to ensure business delivery at the right quality, cost, and speed
- Overseeing several sub-teams such as sample management, reference management, regulatory management, and QC instrument and equipment management
- Leading the team to comply with internal requirements in all aspects through end-to-end quality control system oversight
- Ensuring all activities in the QC team are performed in compliance with cGMP, data integrity, and EHS requirements
- Overseeing the training, evaluation, and management of the staff in the QC lab, including coaching, developing, and supporting them to reach their full potential
- Being responsible for GMP audits from regulatory authorities and clients, responding to audit reports, and creating CAPAs
Qualifications:
- Bachelor’s degree or above in pharmacy, chemistry, biochemistry, analytical chemistry, or other related disciplines
- Minimum of 7 years of working experience in the biotech or biopharma industry
- A good understanding of the overall 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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