Job Description

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

Skills Required