Quality Assurance Manager - Midrand Verfied

Salary Negotiable Midrand, Gauteng Midrand, Gauteng more than 14 days ago 10-02-2016 2:03:37 PM
09-03-2016 2:03:37 PM
Our client in the Midrand area is recruiting for a Quality Assurance Manager, to create awareness, monitor and ensure compliance with Current GMP, MCC regulations, Health and Safety regulations and Hazard analysis and critical control points

1. Quality manual compiling and updating.
2. Overall document control (coordination, initiation, review and approval) for SOPs, updating master specifications, batch packaging records and batch manufacturing records.
3. Perform external audits on suppliers to ensure compliance to factory requirements with GMP. Making sure all reports are written and closed off. This includes approving new suppliers.
4. Ensure compliance to environmental monitoring programs/procedures, calibration schedules, preventative maintenance schedules.
5. Maintaining and updating technical contracts.
6. Control all aspects of change management, i.e. keep track of product, packaging, etc. changes.
7. Follow up and investigate all deviations where the product does not meet quality standards for whatever reason.
8. Follow up and investigate any testing results where an ‘Out of Specification’ was obtained.
9. Control all aspects of Corrective and Preventative Action (CAPA) where/when quality problems occur.
10. In control of investigating customer complaints from the public and giving formal feedback.
11. Annual product reviews on all products.
12. Training (on GMP and all SOPs) across all departments.
13. Assist with documentation as part of the Site Master File i.e. updating the Quality part.
14. Validations (Validation master plan and all validation protocols for all equipment – production and laboratory).
15. Supervising laboratory staff and head of QC (quality control).
16. Maintain a data base for all quality documents.

• B.Pharm Degree/ B. Tech Pharmaceutical Sciences/ Chemistry
• Additional qualifications in Validations and conducting audits would be beneficial.