|Location||Port Elizabeth, South Africa|
|Date Posted||March 6, 2021|
Accounting & Finance
We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.
The main purpose of the job is to manage and ensure an efficient microbiological service, which complies with GMP and GLP principles whilst confirming the application of parenteral control and product quality assurance.
1. Ensure the effective design, sampling and monitoring of all microbiological requirements e.g Environmental Monitoring, Water, Raw Material and Product Bioburden testing and Bacterial Endotoxin (LAL) determinations, Raw Material and Final Product Biological Assays and Sterility Testing, for the FKMSA Site.
2. The development/update and implementation of written procedures and validation protocols, where required.
3. Ensure all documentation and records are logged and up to date in the appropriate logbooks, report sheets etc.
4. Requisition and controlled use of consumable goods and equipment through the implementation of a capex compilation, budget and budget planning.
5. Ensure that the maintenance, validation and calibration of all microbiology laboratory equipment are performed as required.
6. Oversee the completion of all microbiological validation and stability testing requirements.
7. Ensure the implementation of GMP, GLP and Good Housekeeping Practices in the laboratory, ensure correct test performance which will yield valid results, satisfy clothing requirements, and ensure cleaning is to the standards required for each area class.
8. Approval for release of all microbiology related test results.
9. Upgrading of all test methods, equipment and facilities to ensure continued compliance to current standards.
10. Problem solving to resolve out of specification results.
11. Report monthly on department output to indicate microbiological control of factory site.
12. Monitoring and ensuring internal and external audit compliance to both regulatory requirements and standards.
13. Administrative duties to ensure easy retrieval of test results, reports, protocols, etc.
14. Responsible for performing investigations in the area of responsibility, with the support of the tool Kabitrack.
15. From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent.
Budget and Cost Control
16. Control and optimise the cost within the department.
17. Set quality and performance KPI’s for the department and monitor the departmental performance on a defined frequency.
18. Continuously improve processes to introduce World Class Manufacturing practices within the business.
19. Identify opportunities for productivity and efficiency improvements.
Human Resources Management
20. Manage all personnel in the department including disciplinary procedures.
21. Ensure that all personnel in the department is developed and trained as required by the various job functions.
22. Recruitment of staff.
23. Staff development regarding identifying needs and opportunities.
24. Performance Management evaluation.
25. Review salaries and promotions if applicable.
26. Implementation of equity plan as set out in the Employment Equity Policy.
The mandatory minimum experience required is 7 years working experience within a pharmaceutical microbiology laboratory with 2 years supervisory/managerial experience.
Experience within the sterile manufacturing environment will be a clear advantage.