General Employment - Other General Employment
- Ensure that departmental standard operating procedures are reviewed and updated timeously.
- Master material specifications and analytical methods are in line with the latest Pharmacopeia references and regulatory documentation.
- Standard operating procedures are representing actual events and comply with cGMP/GLP requirements.
- Decide whether changes to documentation are acceptable in line with GLP.
- Ensuring that all departmental SOPs are continuously updated with current requirements for GMP.
- Requirements for GLP are documented in SOPs and QC Lab personnel are effectively trained and competent.
- Ensure GMP, GLP, and safety standards are adhered to within the laboratory.
- Compliance with SAPHRA and health and safety requirements.
- Responsible for identifying training needs of direct reports.
- Ensures that staff receive required initial and continued training and assessment and that training records are kept.
- A continuous and periodic formal assessment of the performance of employees.
- Ensure continuous feedback and communication to staff.
- Manpower Retention
- Submit an annual budget for the department.
- Expenditure remains within budget.
- Decide whether overtime is necessary when required.
- Ensure that lab resources are effectively utilised and robust systems are implemented to ensure timeous testing and release of raw materials as per production plans and market demand.
- BSc or National Diploma in Chemistry or related
- 8 years’ Laboratory experience in the pharmaceutical manufacturing industry
- QC Laboratory supervisory experience is required.
- A good understanding of cGMP and GLP is required.
- Familiarity with equipment installation and qualification.
- Experience in LIMS
- Experience interacting with regulatory bodies.
- Computer literacy/MS Office
- Understanding of data integrity
- Understanding of SAHPRA and WHO requirements