Site Quality Head & Pharmacist

SUMMARY:
Our client in the Pharmaceutical Sector is seeking an experienced and dedicated Quality Head & Responsible Pharmacist to oversee their quality assurance processes and ensure compliance with regulatory standards.

POSITION INFO:
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 company’s global Quality Network
• To fulfil the role of site Responsible Pharmacist and to manage Pharmaceutical Services of the company

• 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