Quality Assurance Manager

3 days ago

Nantou Tainan City, Taiwan EPM Scientific Full time NT$900,000 - NT$1,200,000 per year

OPEN TO RELOCATING CANDIDATES

Our client is a leading global pharmaceutical company focused on developing high-quality, affordable medicines through advanced research and regulatory excellence. They are currently looking for a
Quality Assurance Manager
to lead and oversee analytical development and validation activities within a regulated pharmaceutical environment.

Responsibilities

  • Lead analytical method development and validation for drug substances and finished products, including dissolution, stability, and reverse engineering studies.
  • Oversee method transfer processes and support regulatory submissions such as NDA and ANDA.
  • Supervise and mentor laboratory staff, ensuring adherence to GMP, SOPs, and safety protocols.
  • Manage project timelines, resource allocation, and technical support, while communicating progress to senior leadership.
  • Ensure proper use, calibration, and qualification of analytical instruments and support procurement of new equipment.
  • Review and approve analytical protocols, reports, and CMC documentation, ensuring data integrity and regulatory compliance.
  • Lead investigations, CAPAs, and internal audits, and contribute to continuous improvement of quality systems.

Requirements
:

  • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field.
  • Minimum 8 years of experience in pharmaceutical quality assurance or analytical development.
  • Strong knowledge of GMP regulations and global regulatory requirements.
  • Proven leadership and team management skills, including performance reviews and conflict resolution.
  • Experience with documentation systems, equipment qualification (URS, DQ, IQ, OQ, PQ), and regulatory submissions.
  • Ability to stay current with industry trends, regulatory updates, and best practices.

If you are interested, please apply with your updated CV.

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