QC Raw Materials Manager
Dalitso Holdings
Midrand, Gauteng, ZA
5d ago
  • 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.
  • Minimum Requirements :

  • 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
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