Site Quality Head & Responsible Pharmacist

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 of Compliance with international statutory & GMP requirements

Assuring of Compliance with global Quality Standards

Acting as 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 eg MHRA, TGA. ANVISA and 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