Site Quality Head & Responsible Pharmacist

at  Fresenius Kabi

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.
We are dedicated to a higher purpose “caring for life” which drives excellence in everything we do.
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.
The main purpose of the Site Quality Head & Responsible Pharmacist is:
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 Fresenius Kabi Quality Standards
Acting as interface to Fresenius Kabi corporate Quality Functions and Quality Units of other Fresenius sites
Integrating and aligning the site within the Fresenius Kabi global Quality Network
To fulfil the role of site Responsible Pharmacist and to manage Pharmaceutical Services of the company

• 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