Site Quality Head
2 months ago
Job Responsibilities:
- Management of the Quality Unit of Production Unit
- Development of Quality Culture in Production Unit
- Strategic Development & Improvement of Quality Compliance of Production Unit to meet international standards
- Assuring of Compliance with international statutory & GMP requirements
- Assuring of Compliance with global company Quality Standards
- Acting as interface to company corporate Quality Functions and Quality Units of other company sites
- Integrating and aligning the site within the companys global Quality Network
- To fulfil the role of site Responsible Pharmacist and to manage Pharmaceutical Services of the company
Job Requirements:
- 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 eg MHRA, TGA. ANVISA and WHO
- Experience of managing an independent multi-function site with multi-disciplinary teams
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