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Site Quality Head & Responsible Pharmacist

Fresenius Group • Full-time • Port Elizabeth, Eastern Cape, South Africa • 6h ago

Job title : Site Quality Head & Responsible Pharmacist

Job Location : Eastern Cape, Port Elizabeth Deadline : December 11, 2024 Quick Recommended Links

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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