Site Quality Head & Responsible Pharmacist at Fresenius Group

General Duties

• Assuring that the site Quality Management System facilitates the full legal pharmaceutical responsibilities of the Responsible Pharmacist according to:
• SAHPRA for compliance with the requirements of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and the Pharmacy Council for compliance with the requirements of the Act, 1974 (Act 53 of 1974) Annex 16 to the SA Guide to GMP.
• Collaborating with Plant Management and QA and Operations Management in decision taking on the strategic development of PU Port Gqeberha, Involvement with investment decisions at PU Gqeberha.
• All Quality Management principles and techniques, in Quality System per ICH Q10, Qualification & Validation (Process, Cleaning Validation, Computerized Validation), Quality Risk Management (ICH Q9), Root-Cause-Assessment, Data Governance should be intimately know
• Assuring of operational efficiency of departments of the site Quality Unit
• Assuring of compliance with the relevant Good Manufacturing Practices (GMP)
• Implementation and maintenance of a Pharmaceutical Quality System (PQS) in-line with the Fresenius Kabi global Quality Management System and the statutory requirements
• Management of medicine registration applications for imported and locally produced products in various countries outside South Africa
• Maintenance of site certifications & licences
• Assurance that facilities, utilities & equipment are qualified, and that methods & processes are validated according to GMP-requirements
• Representation of the company / the site in audits and inspections, towards international competent authorities
• Representation of PU Gqeberha in company committees, meetings etc.
• Oversee the development, implementation of and the adherence to the Standard Operating Procedures (SOP’s) in the department
• Manage the Internal Audit & Supplier Audit Programme
• Overseeing the handling of quality deficiencies, product failures, root cause analysis, and implementation of Corrective and Preventive actions, recording and trending of data.
• Overall responsibility for the core processes systems of the Quality
• Management System, e.g. Deviation Management, CAPAs, Document Control, Quality Risk Management, Root Cause Analysis and Change Control
• Overall responsibility for Product Quality Review process in accordance with GMP requirements
• Overseeing compilation of Management Review
• Overseeing the Complaints Handling process
• Overseeing Vendor Management Programme
• Implementation of Quality Risk Management & Continual Improvement systems and programmes
• Overall responsibility for QA approval of all GMP Training Material and programmes
• Overall responsibility for authorization of SOP’s and other Quality documents, including amendments
• Overall responsibility for the Document Control and retention system
• Overseeing Quality Control activities
• Overseeing Regulatory Affairs activities
• Overseeing Releases
• Establishing quality metrics, data collection, trending and analysis of KPI’s
• Systems

Budget & Cost Control

• Develop and control the financial budget for the department
• Control and optimise the cost within the department
• Set quality and performance KPI’s for the department and monitor the departmental performance on a defined frequency
• Develop strategic roadmap for the department to meet market and business requirements for the present and future conditions

​​​​​​​People Management

• Manage all personnel in the department and provide ongoing performance feedback to staff as and when required
• Ensure that all personnel in the department is developed and trained as required by the various job functions
• Ensure best working practices within the department
• Set quality and performance KPI’s for the department and monitor the departmental performance on a defined frequency

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