Quality Assurance

Job Function:

1. Directly responsible for quality assurance of the pharmaceutical drug products by enforcing SFDA

requirements, Good Manufacturing Practices and other quality related tools in order to meet the

quality regulations.

2. Review drug product Batch Records and other manufacturing related documents to verify

compliance and record keeping for all mandated manufacturing process, quality checks, testing,

sampling and sanitization activities.

3. Quality Audits related to API, Packaging Components, Labels, and finished products to ensure

compliance with established specifications and regulatory standards.

4. Follow up with implemented programs (GMPs, Good Hygiene Practices, HACCP, Allergen

Control, Cleaning and Sanitization, Pest Control, Equipment Calibration etc.) to ensure

compliance by all employees and other personnel involved in the production process in the

manufacturing facility. 

5. Follow up the destruction process with SFDA

6. Co-ordinate for the testing results availability involving finished products, raw materials and

packaging components and the appropriate release and hold programs associated with these

materials.

7. Oversee the “On Hold” product program, including the status, release and destruction of Drug

Products including its tailings.

8. Assist in investigating and correcting quality-related issues (including customer complaints)

through proper collaboration with other departments

9. Ensure good performance by quality assurance by mentoring, training, setting expectations,

providing accountability evaluations.

10. Perform other Quality Assurance duties as directed by the Quality Assurance Supervisor

11. Responsible to maintain competence in all responsibility of a Quality Assurance Officer