Responsible Pharmacist - Supply Operations Quality Manager

The primary purpose of this position is to serve as the Responsible Pharmacist (RP) for Pfizer Laboratories (Pty) Ltd and to exercise the professional, statutory and regulatory accountability required for the licensed manufacturing pharmacy and legal entity in South Africa. The RP ensures that the company and pharmacy operate in compliance with the Pharmacy Act, 53 of 1974, the Medicines and Related Substances Act, 101 of 1965, applicable regulations, Good Pharmacy Practice, relevant SAHPRA and SAPC requirements, and all conditions and limitations of the licenses held by the company.   In addition, the role provides focused SOQ management support by maintaining effective local product quality systems, coordinating product quality issue management, and overseeing outsourced GMP/GDP activities. These SOQ responsibilities are performed under the direction of the SOQ Sub-Cluster Lead, while the RP retains independent professional judgement and final accountability for matters reserved to the Responsible Pharmacist. 1. Responsible Pharmacist – statutory, license and legal-entity accountability Act as registered with the South African Pharmacy Council and formally appointed as Responsible Pharmacist for Pfizer Laboratories (Pty) Ltd. Exercise personal supervision and independent professional judgement over pharmacy activities and ensure compliance with the Pharmacy Act, Medicines and Related Substances Act, applicable regulations, Good Pharmacy Practice, GDP and relevant SAHPRA/SAPC requirements. Ensure that the GMP-pharmacy license and SAHPRA license remain valid, accurate, and renewed on time, and that the SAPC and other authorities are informed as required. Ensure operations remain strictly within approved license conditions, including the non-stock-holding premises condition and the authorized import/export scope. Prevent unapproved testing, distribution, material handling, or storage at the licensed premises. Assess proposed changes to the legal entity, premises, responsible personnel, quality systems or licensed activities and ensure required regulatory notifications or prior approvals are obtained before implementation. Act as the official pharmaceutical contact and authorized signatory for SAHPRA, SAPC, the Department of Health and other competent authorities on matters requiring RP accountability. Oversee and approve regulatory submissions, notifications, responses and commitments involving pharmacy or product-quality compliance, ensuring accuracy and completion within statutory timelines. Represent the legal entity during regulatory inspections and ensure observations; commitments and corrective actions are appropriately addressed and closed. Ensure documented deputy and delegation arrangements provide continuous statutory coverage during RP absence, without transferring the RP’s ultimate professional accountability. Provide professional pharmaceutical guidance to senior management and escalate any activity that may compromise patient safety, product quality, license compliance or the lawful conduct of the pharmacy. Exercise oversight and supervision of the Regulatory, Medical, Pharmacovigilance and other GxP functions for any submission, notification or interaction with the Board of Health (BoH), ensuring that all filings, responses and commitments are accurate, compliant and completed within the required statutory timelines. 2. Responsible Pharmacist – product control and market decisions Maintain full oversight of medicines imported or exported by the legal entity and confirm that activities comply with product registrations, permits, license conditions and applicable regulatory requirements. Hold final RP decision-making authority for returned medicines, including documented assessment and disposition as return to saleable stock, quarantine or destruction, in accordance with applicable legislation, GDP and Pfizer requirements. Authorize or provide required RP approval for product release, quarantine, rejection,