Quality Assurance Associate / Specialist
About the Role
We are looking for a detail-oriented and proactive Quality Assurance professional to join a pharmaceutical organization. This role will help ensure that products placed on the market consistently meet applicable quality, safety, regulatory, and compliance requirements.
The successful candidate will work closely with internal stakeholders, third-party manufacturers, distributors, and suppliers to support the effective implementation and maintenance of the Quality Management System and relevant GxP standards, including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
Qualifications
- Bachelor's Degree in Pharmacy is required.
- Must be a Licensed Pharmacist with a valid PRC license.
- At least three (3) years of experience in Quality Assurance within a local or multinational pharmaceutical company.
- Working knowledge of GMP, GDP, Quality Management Systems, and applicable pharmaceutical regulatory requirements.
- Strong attention to detail, analytical and problem-solving skills.
- Ability to manage documentation, coordinate with multiple stakeholders, and follow through on quality-related activities.
Key Responsibilities
Quality Systems and Compliance
- Support the implementation, monitoring, and continuous improvement of quality initiatives and programs.
- Monitor quality-related activities and provide relevant updates and reports to management.
- Review and assess change controls, particularly those with potential impact on product quality, safety, and regulatory status.
- Ensure that quality-related changes receive the necessary review and approval before implementation.
- Maintain accurate, complete, and traceable quality documentation in accordance with established QMS and archiving requirements.
Product Quality Oversight
- Ensure that locally and internationally manufactured products meet approved specifications and applicable quality requirements prior to market release.
- Review product and process deviations, out-of-specification (OOS) results, complaints, recalls, and other quality events to ensure appropriate reporting, investigation, resolution, and documentation.
- Review technical reports and relevant quality documentation submitted by third-party or toll manufacturers.
- Assess Annual Product Reviews or equivalent product quality reports and communicate relevant findings.
- Evaluate product returns and recommend appropriate disposition in accordance with established procedures.
- Monitor the proper handling and destruction of damaged, expired, or non-conforming materials and products.
Third-Party and Distribution Quality Management
- Maintain oversight of Quality Agreements with third-party manufacturers, distributors, and suppliers.
- Support the audit and assessment of external partners to verify compliance with GMP, GDP, QMS, and applicable regulatory requirements.
- Coordinate with distributors on quality-related activities, including redressing, repackaging, product returns, and other approved product handling activities.
- Conduct or support inspections of damaged stocks at distributor warehouses and ensure appropriate follow-up and disposition.
Packaging and Materials Review
- Review and monitor the quality of packaging materials throughout the development process, from artwork through finished product.
- Review promotional and non-promotional materials for compliance with applicable quality and approval requirements.
Other Responsibilities
- Perform other quality-related duties and responsibilities that may be assigned from time to time based on business and operational requirements.
