Management of the Quality Unit of Production Unit Gqeberha.
Development of Quality Culture in Production Unit Gqeberha.
Strategic Development & Improvement of Quality Compliance of Production Unit Gqeberha to meet international standards.
Assuring Compliance with international statutory & GMP requirements.
Assuring Compliance with global Quality Standards.
Acting as an interface to corporate Quality Functions and Quality Units of other sites.
Integrating and aligning the site within the global Quality Network.
To fulfil the role of site Responsible Pharmacist and to manage Pharmaceutical Services of the company.
Formal Qualifications
- B. Pharm/ Dip. Pharm essential.
- Registration with SAPC essential.
- Minimum 5 years managerial & leadership experience in Pharmaceutical production environment.
- Minimum 5 years managerial experience in Quality Management / Quality Assurance.
- Minimum of 3 years managerial experience in pharmaceutical responsibility for finished products, either in direct role or in leadership of Responsible Pharmacist or EU Qualified Person or Authorized Person or similar functions.
- Aseptic Manufacturing experience essential.
- Extensive experience with SAHPRA.
- Extensive experience in managing & leading inspections from SAHPRA.
- Extensive experience with international competent authorities such as US-FDA, EU Authorities e.g. MHRA, TGA, ANVISA, WHO.
- Extensive experience in managing & leading inspections from international competent authorities such as US-FDA, EU Authorities e.g. MHRA, TGA, ANVISA, WHO.
- Experience of managing an independent multi-function site with multi-disciplinary teams.
- Skills Matrix Site Quality Head and Responsible Pharmacist role for local SOPs.
More information pertaining to the duties available upon request.
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