Head of Quality & Responsible Pharmacist

SUMMARY:
Our client in the Pharmaceutical Industry, is looking to employ a skilled and experience Head of Quality & Responsible Pharmacist, to their team in Port Elizabeth.

This vacancy has been marked as an equity appointment.

An exciting career opportunity await you!

POSITION INFO:
Main Purpose of the Job :

• Management of the Quality
• Development of Quality Culture
• Strategic Development & Improvement of Quality Compliance to meet international standards
• Assuring of Compliance with international statutory & GMP requirements
• Assuring of Compliance with global Quality Standards
• To fulfil the role of site Responsible Pharmacist and to manage Pharmaceutical Services of the company

• Pharm or Dip. Pharm is essential.
• Registration with SAPC is essential.
• Minimum of 5 years of managerial and leadership experience in a pharmaceutical production environment.
• Minimum of 5 years of managerial experience in Quality Management or Quality Assurance.
• Minimum of 3 years of managerial experience in pharmaceutical responsibility for finished products, in roles such as Responsible Pharmacist, EU Qualified Person, or Authorized Person.
• Aseptic manufacturing experience is essential.
• Extensive experience with SAHPRA and in managing inspections from SAHPRA.
• Extensive experience with international competent authorities such as US-FDA, EU authorities like MHRA, TGA, ANVISA, WHO.
• Extensive experience in managing and leading inspections from international competent authorities such as US-FDA, EU Authorities eg MHRA, TGA, ANVISA, WHO.
• Experience managing an independent multi-function site with multi-disciplinary teams.

• Ensure 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 and the Pharmacy Council for compliance with the requirements of Act, 1974 Annex 16 to the SA Guide to GMP.
• Collaborate with plant management and QA and Operations Management in decision taking on the strategic development off the site.
• Possess a comprehensive understanding of Quality Management principles and techniques, in Quality system per ICH Q10, Qualification and Validation, Quality Risk Management (ICH Q9), Root-cause-Assessment and Data Governance.
• Ensure operational efficiency of departments of the site Quality Unit.
• Assuring compliance with Good Manufacturing Practices (GMP).
• Implement and maintain a Pharmaceutical Quality System (PQS) in-line with the company's global Quality Management System and statutory requirements.
• Manage medicine registration applications for imported and locally produced products in various countries outside South Africa.
• Maintain site certifications and licenses.
• Assurance that facilities, utilities and equipment are qualified, and that methods and processes are validated according to GMP-requirements.
• Representation of the company / the site in audits and inspections, towards international competent authorities.
• Oversee the development, implementation of the adherence to the standard operating procedures (SOP’s) in the department.
• Manage the internal audit and supplier audit program.
• 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, CAPA’s, 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, the complaints handling process and the vendor management programme.
• Implementation of quality risk management and 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, regulatory affairs activities and 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.