Site Quality Head & Responsible Pharmacist

Fresenius Kabi

1mo ago

Job
Full-time
Senior & Expert Level
Healthcare
Port Elizabeth

AI generated summary

You need a B. Pharm/Dip. Pharm, SAPC registration, 5+ years in pharmaceutical leadership, quality management, and aseptic manufacturing, plus experience with SAHPRA and international inspections.
You will manage the Quality Unit, ensure compliance with GMP and global standards, oversee audits, facilitate training, handle quality deficiencies, and develop strategic plans for continuous improvement.

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

Responsibilities

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
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
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

FAQs

What is the main purpose of the Site Quality Head & Responsible Pharmacist role?

The main purpose is to manage the Quality Unit of Production Unit Gqeberha, develop a quality culture, and ensure compliance with international standards and regulations.

What qualifications are required for this position?

A B. Pharm or Dip. Pharm is essential, along with registration with SAPC.

How many years of managerial experience are required?

A minimum of 5 years of managerial and leadership experience in a pharmaceutical production environment and quality management/quality assurance is required, as well as at least 3 years of managerial experience related to pharmaceutical responsibility for finished products.

Is aseptic manufacturing experience necessary for this role?

Yes, aseptic manufacturing experience is essential.

What authorities do candidates need experience with?

Candidates should have extensive experience with SAHPRA and international competent authorities such as US-FDA, EU Authorities (e.g. MHRA), TGA, ANVISA, and WHO.

Will the Site Quality Head be involved in audits and inspections?

Yes, the Site Quality Head will represent the company and site in audits and inspections towards international competent authorities.

What are the responsibilities related to budget and cost control?

The responsibilities include developing and controlling the financial budget for the department, optimizing costs, and setting quality and performance KPIs.

Will the Site Quality Head be responsible for personnel management?

Yes, the Site Quality Head will manage all personnel in the department and provide ongoing performance feedback, as well as ensure staff development and training.

What kind of experience is necessary for managing inspections?

Extensive experience in managing and leading inspections from SAHPRA and other international competent authorities is required.

How does this position contribute to quality compliance?

This position assures compliance with international statutory and GMP requirements, implements and maintains a Pharmaceutical Quality System, and oversees various quality control and assurance activities.

Fresenius Kabi

Manufacturing & Electronics

Industry

10,001+

Employees

1912

Founded Year

Mission & Purpose

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its “Vision 2026”, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.