Quality Assurance Specialist – Pharmaceutical

About the role

We are seeking a detail‑oriented Quality Assurance Specialist to join a pharmaceutical organization. The role ensures that all products released to the market consistently meet quality, safety, regulatory, and compliance standards.

Key responsibilities

• Support implementation, monitoring, and continuous improvement of quality initiatives and programs.
• Review and assess change controls, ensuring proper review and approval before implementation.
• Maintain accurate, traceable quality documentation in line with the QMS and archiving requirements.
• Verify that locally and internationally manufactured products meet approved specifications before market release.
• Investigate product deviations, OOS results, complaints, recalls, and other quality events, ensuring proper reporting and resolution.
• Assess technical reports from third‑party manufacturers and conduct annual product reviews.
• Oversee quality agreements with third‑party manufacturers, distributors, and suppliers, and support external audits.
• Coordinate with distributors on quality‑related activities such as redressing, repackaging, and product returns.

Required profile

• Bachelor’s Degree in Pharmacy.
• Valid PRC license as a Licensed Pharmacist.
• Minimum three (3) years of Quality Assurance experience in a local or multinational pharmaceutical company.
• Strong attention to detail, analytical and problem‑solving abilities.
• Ability to manage documentation and coordinate with multiple stakeholders.

Required skills

• Working knowledge of Good Manufacturing Practice (GMP).
• Working knowledge of Good Distribution Practice (GDP).
• Familiarity with Quality Management Systems.
• Understanding of applicable pharmaceutical regulatory requirements.