Quality Control Manager

1 week ago


Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time
Roles & Responsibilities

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

Tell employers what skills you have

Coaching
Biochemistry
Analytical Chemistry
Drug Development
USP
FDA
Quality Control
ANDA
GMP
Investigation
Chemistry
Compliance
Audit
EHS

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