Responsible Pharmacist

We are recruiting on behalf of a client for an experienced Responsible Pharmacist to provide independent pharmaceutical oversight and ensure the licensed pharmaceutical facility operates in full compliance with statutory, professional and regulatory requirements. The ideal candidate will bring extensive pharmaceutical manufacturing experience, strong leadership capability and in-depth knowledge of SAPC, SAHPRA, GMP and GPP requirements.

Responsibilities:

• Fulfil all statutory and professional responsibilities of the Responsible Pharmacist.
• Ensure compliance with the Pharmacy Act, Medicines and Related Substances Act, SAPC requirements, SAHPRA licence conditions and applicable GMP/GPP standards.
• Maintain oversight of medicines and scheduled substance control, including compliant storage, distribution and record keeping.
• Oversee batch disposition, product release and rejection activities where appropriately authorised.
• Supervise pharmacists and pharmaceutical personnel and maintain effective delegation controls.
• Provide oversight of the Pharmaceutical Quality System, including deviations, CAPAs, change controls and quality risk management.
• Manage regulatory inspections, commitments and engagements with SAPC, SAHPRA and other relevant authorities.
• Oversee product complaints, quality defects, recalls and reportable events.
• Identify and escalate significant product quality, patient safety and regulatory compliance risks.
• Promote a strong culture of pharmaceutical compliance, ethical conduct, training and continuous improvement.
• Collaborate with Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain and Operations.

Requirements:

• BPharm Degree.
• Registered as a Practising Pharmacist with the South African Pharmacy Council (SAPC).
• Minimum of 5 years' post-community service experience within a pharmaceutical manufacturing environment.
• Strong knowledge of the Pharmacy Act, Medicines and Related Substances Act, SAPC requirements and SAHPRA regulatory requirements.
• In-depth understanding of pharmaceutical Quality Management Systems, GMP/GPP, medicines control and regulatory compliance.
• Strong experience in regulatory inspections, audit readiness, CAPAs, deviations, change control and quality risk management.
• Excellent leadership, stakeholder management, analytical and problem-solving skills.
• More than 5 years' post-community service experience in sterile pharmaceutical manufacturing.
• In-depth working knowledge of Annex 1 of the PIC/S GMP Guide (PE 009-17).
• No less than 5 years' post-community service experience in pharmaceutical manufacturing.
• In-depth working knowledge of Annex 9 of the PIC/S GMP Guide.

EE Disclaimer:

All positions will be filled in accordance with the company's Employment Equity plan. We encourage people with disabilities to apply.

Application Unsuccessful Disclaimer:

If you do not receive feedback within two weeks of your application, please consider it unsuccessful. Keep an eye on our website and other career sites for future opportunities.

REF: TC01