Responsible Pharmacist Deputy

Responsible Pharmacist Deputy - Quality Manager Join to apply for the Responsible Pharmacist Deputy - Quality Manager role at Fresenius Medical Care Responsibilities Implement, maintain, and improve the local QMS in alignment with global and regulatory standards. Lead management reviews, internal audits, quality improvement projects, and compliance monitoring activities. Ensure full compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), GxP, and Pharmacy Act requirements. Support SAHPRA inspections, internal and external audits, including preparation, hosting, and CAPA management. Act as Deputy to the Responsible Pharmacist in their absence; assist in performing all regulatory responsibilities as defined under the Pharmacy Act. Ensure that all activities related to procurement, storage, handling, distribution, and quality control of pharmaceutical products and medical devices comply with legal and ethical standards. Monitor and ensure compliance with conditions of registration, licenses, and permits (e.g., SAHPRA, SAPC). Maintain oversight of batch release, recall processes, and documentation as required by the South African regulatory framework. Ensure the proper recording and reporting of product complaints and adverse events in collaboration with pharmacovigilance and regulatory teams. Liaise with SAPC and other authorities as needed. Manage SOPs, policies, and other controlled documents; oversee document lifecycle, archival, and version control per corporate guidelines. Lead change control processes, ensuring all proposed changes are assessed for quality and compliance impact. Ensure product quality compliance across all stages from receipt to final distribution. Review and approve quality records, deviations, non-conformances, and batch documentation. Qualify and audit external service providers (e.g., transporters, warehousing, contract labs); ensure suppliers adhere to quality agreements and meet performance expectations. Ensure third‑party intermediaries operating as distributors comply with local regulatory requirements and contractual quality agreements. Conduct regular performance assessments, quality audits, and risk evaluations of third‑party distributors. Report and manage product complaints, deviations, and quality incidents promptly. Implement and periodically review Quality/Technical Agreements with all third‑party distributors. Establish and maintain GxP training programs for all relevant staff; ensure personnel are trained and competent. Lead quality risk assessments and implement risk mitigation strategies. Collaborate with cross‑functional teams to proactively address quality concerns. Support local pharmacovigilance and product recall activities in compliance with regulatory requirements; participate in mock recalls and coordinate timely execution of recall procedures. Prepare and communicate quality metrics and reports to management and global quality teams. Escalate quality or compliance issues to senior leadership as necessary. Qualifications Bachelor of Pharmacy (BPharm) and registration with the South African Pharmacy Council (SAPC) are mandatory. Minimum 3 years of experience in pharmaceutical quality management or regulatory compliance. Strong knowledge of SAHPRA regulations, Pharmacy Act, GMP, GDP, and GxP standards. Previous experience acting as or supporting a Responsible Pharmacist is an advantage. Familiarity with multinational/matrix environments is preferred. Employment Details Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Quality Assurance Industries: Hospitals and Health Care Location: Kempton Park, Gauteng, South Africa #J-18808-Ljbffr