- Job Title QA Pharmacist - Pharmaceuticals
To ensure that all quality matters and all aspects of the operational business comply with GxP, legal and regulatory requirements and the Company Corporate Quality Manual and Policies.
Prevent significant quality issues or regulatory non-compliance which could lead to product stock-out or withdrawal, or which would negatively impact the company as well as its reputation.
Support the Quality/ NCQ in the movement towards a state of perpetual compliance.
1. Perform batch record review and related activities (e.g. PIT, reference standards ordering and management, import permit application, method transfer, sample and temperature checks) for timely market & technical release of finished goods.
2. Perform Product Quality Reviews (PQR) and Batch Manufacturing Documentation Reviews according to schedule in order to monitor the quality of products and compliance against the marketing authorization.
3. Raise, investigate, manage and actively resolve quality investigations as needed e.g. deviations, complaints, CAPAs, QEs in conjunction with third parties and operational units to minimize impact on product availability and sales.
4. Create and maintain GxP documentation e.g. SOP’s, BRCF’s, product master files, tracking sheets etc.
5. Perform self-inspections and supplier/third party assessments according to schedule. Propose and monitor actions to improve/maintain quality standards. Participate in GCA audits
6. Provide QA/QC support for product launches. Ensure participation in launch meetings, and that
all quality related activities are in place tor timely testing and batch releases for a smooth product launch.
7. Artwork approval: Artwork approval: timely and accurate review and approval of packaging component artwork.
8. Performance measures- Accurately produce assigned KQI measures in a timely way.
9. Day-to-day coordination and communication with external functions, e.g. distributors, analytical laboratory, customers
11. Perform product batch manufacturing record reviews according to schedule in order to monitor compliance of manufactured product to the regulatory dossier.
12. Manage goods for destruction
13. Perform product return evaluations and determine disposition
14. Act as deputy for the handling of technical product complaints and related performance measures.
15. Perform training to ensure continuous quality maintenance and quality improvement.
16. Deputize for when out of office and Quality Unit Head as needed.
17. Take responsibility for corporate citizenship within the sphere of influence and control, and to enforce the Company Code of Conduct.
Education: B. Pharm or Dip. Pharmacy
Experience/ Professional requirement:
1. Registered with the South African Pharmacy Council.
2. Minimum of 2 years in the pharmaceutical industry (quality assurance, quality control, registration or production) or a directly related field.
3. Good knowledge and understanding of GMP, quality systems and quality practices. Product release, documentation, process and third party management. High compliance. Planning & organizing, analytical, communication and inter- personal skills.