**Quality Management System (QMS)** + 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. **Regulatory Compliance & Inspections** + 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. **Deputy Responsible Pharmacist Duties** + Act as **Deputy to the Responsible Pharmacist** in their absence and assist in the performance of all regulatory responsibilities as defined under the Pharmacy Act. + Ensure that all activities related to the procurement, storage, handling, distribution, and quality control of pharmaceutical products and medical devices are conducted in accordance 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 the SAPC and other authorities as needed **Documentation & Change Control** + Manage SOPs, policies, and other controlled documents. Oversee document lifecycle, archival, and version control as per the corporate guidelines. + Lead change control processes, ensuring all proposed changes are assessed for quality and compliance impact. **Product Quality Oversight** + Ensure product quality compliance across all stages from receipt to final distribution. + Review and approve quality records, deviations, non-conformances, and batch documentation. **Supplier & Third-Party Oversight** + Qualify and audit external service providers (e.g., transporters, warehousing, contract labs). + Ensure suppliers adhere to quality agreements and meet performance expectations. **Management of third-party intermediaries (TPI) acting as distributors for the company in SSA countries:** + Ensure the TPI are operating in accordance with local regulatory requirements and applicable licenses. + Supervise the compliance with contractual and quality agreements, including product handling, storage, distribution, and documentation standards. + Undergo regular performance assessments, quality audits, and risk evaluations. + Report and manage product complaints, deviations, and quality incidents in a timely and compliant manner. + Ensure clear and effective communication channels between the company and third-party partners to support product quality and patient safety. + Lead the implementation and periodic review of Quality/Technical Agreements with all third-party distributors. **Training & Development** + Establish and maintain GxP training programs for all relevant staff. + Ensure personnel involved in the handling of medicines and medical devices are trained and competent. **Quality Risk Management** + Lead quality risk assessments and implement risk mitigation strategies. + Collaborate with cross-functional teams to proactively address quality concerns. **Pharmacovigilance and Product Recalls** + Support local pharmacovigilance and product recall activities in compliance with regulatory requirements. + Participate in mock recalls and coordinate timely execution of recall procedures when needed. **Reporting & Communication** + Prepare and communicate quality metrics and reports to management and global quality teams. + Escalate quality or compliance issues to senior leadership as necessary. **1) Required training and education:** + Bachelor of Pharmacy (BPharm) and registration with the South African Pharmacy Council (SAPC) is mandatory. **2) Required professional experience:** + 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