We are looking for a Quality Assurance Officer (IPQA) to ensure that all products and processes meet established quality standards across manufacturing, packaging, and warehouse operations, while maintaining full compliance with regulatory requirements.
Main Responsibilities
- Review documents to ensure compliance with GMP and SFDA requirements
- Perform line clearance, in-process inspections, and physical testing in production areas
- Identify, investigate, and report quality issues according to SOPs
- Perform stage approval for production and dispensing activities
- Ensure effective implementation of the Pharmaceutical Quality Management System (SFDA Chapter 1)
- Monitor and enforce quality standards across production and warehouse departments
- Oversee sampling activities (finished products, reserves, stability, bulk, semi-finished, validation samples)
- Ensure compliance within manufacturing, packaging, and warehouse areas
- Participate actively in deviation investigations and reporting
- Approve packaging materials (cartons, leaflets, labels, primary packs) as per SOP
- Review documents and verify Process Operating Instructions (POI)
- Participate in process validation batches according to approved protocols
- Ensure personal hygiene, cleanliness, and adherence to HSE standards at all times
- Conduct process checks and inspections of finished goods
- Ensure compliance with documentation systems, cGMP, and data integrity requirements
- Review batch records and support finished goods release in line with SOPs
- Support data collection and reporting for Product Quality Review (PQR)
- Perform IPQA activities as assigned by the supervisor
- Ensure compliance with safety, quality, and environmental policies and procedures
Qualifications
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related field
- 1–3 years of experience in a quality assurance role (pharma, biotech, or food industry preferred)
- Good knowledge of GMP and regulatory requirements (SFDA, EMA, etc.)
- Strong analytical skills and attention to detail
- Good communication and teamwork abilities
- Knowledge of HSE and OSHA standards and compliance
