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Quality Control Manager (Operation)

Salary undisclosed

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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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