Site Quality Head

2 weeks ago


Gqeberha, South Africa Staff Solutions Recruitment Full time
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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