Responsible Pharmacist

Purpose of the Job

The Responsible Pharmacist ensures statutory compliance, quality assurance, and operational integrity across pharmaceutical and medical device activities. This role oversees licensing, regulatory adherence, and Good Pharmacy, Wholesaling, Manufacturing and Distribution Practices, while safeguarding scheduled products and supervising warehouse operations. It involves implementing and maintaining Quality Management Systems (QMS), conducting audits, facilitating training, and acting as the Pharmacovigilance Responsible Person to ensure safe handling, storage, and distribution of medicinal products in line with SAPC, SAHPRA, ISO, and DOH requirements.

Key Responsibilities

Quality Management and Compliance

• Ensure ongoing certification against ISO 9001 and ISO 13485 standards, as well as compliance with licences issued by SAPC, SAHPRA, and the Department of Health.
• Establish, implement, and uphold all procedures required for a successful Quality Management System in line with regulatory standards.
• Compile detailed Quality Management System reports specific to pharmaceuticals and medical devices, and provide structured feedback to senior leadership.
• Identify corrective actions and promote continuous improvement opportunities across pharmaceutical and medical device operations.
• Maintain accurate Quality Management System documentation and filing systems, ensuring accessibility and compliance.
• Prepare, schedule, and facilitate Management Review Meetings, ensuring all required inputs are captured and documented.

Regulatory and Licensing

• Act as the primary contact with SAPC and SAHPRA, ensuring compliance with statutory requirements and Good Pharmacy Practice.
• Ensure warehouse licences remain valid, annual fees are paid, and any changes to licensing conditions or Site Master Files are promptly reported.
• Guarantee continuous pharmacist oversight of wholesale pharmacy operations to ensure compliance with statutory requirements.
• Restrict access to scheduled medicines, medical devices, and IVDs, ensuring lawful distribution only to licensed entities.
• Ensure contracts and Service Level Agreements are in place with clients and service providers, clearly defining responsibilities under Good Wholesaling / Manufacturing Practice.
• Confirm that all clients hold valid licences and that products originate from legitimate, SAHPRA‑registered sources.
• Act as the designated Pharmacovigilance Responsible Person, receiving and forwarding Adverse Drug Reactions promptly to the relevant stakeholders.
• Purchase and maintain updated reference books and ensure compliance with Regulation 1.2 of the Pharmacy Act.

Operations

• Supervise pharmaceutical warehouse activities including receiving, storage, quarantine, picking, packing, and stock counts.
• Ensure adherence to occupational health and safety requirements across pharmaceutical storage areas.
• Record and report any out‑of‑limit situations to the Quality Assurance Manager, ensuring corrective measures are implemented.
• Ensure all personnel working in pharmaceutical storage areas are appropriately qualified and trained to perform their assigned functions.
• Prevent unauthorised access to restricted pharmaceutical storage areas outside of trading hours.
• Maintain precise records of receipt, possession, storage, safekeeping, and return of pharmaceutical products.
• Participate in continuing professional development programmes and ensure locum availability during periods of absence.

Training

• Plan, schedule, and conduct training sessions on Quality Management System procedures specific to pharmaceuticals and medical devices.
• Maintain accurate training records in line with company procedures and regulatory expectations.

Audits

• Plan and conduct internal quality audits, ensuring findings are documented and addressed in full.
• Action corrective measures and ensure satisfactory resolution of audit findings.
• Liaise with regulatory and customer auditors, preparing documentation and facilitating audit processes.
• Actively participate in external audits, ensuring compliance and readiness at all times.

Minimum Requirements

• Bachelor of Pharmacy degree (BPharm) recognised by SAPC.
• Registration with SAPC as a Pharmacist.
• Valid Responsible Pharmacist designation approved by SAPC.
• 3+ years’ experience in the wholesaling/manufacturing of pharmaceutical and/or medical device products
• Intermediate proficiency in Microsoft Office Suite, with the ability to prepare compliance reports, maintain audit records, and create structured documentation in Word, Excel, and Outlook.
• Advanced capability in Quality Management System software, enabling accurate tracking of ISO compliance, corrective actions, and audit close‑outs.
• Competence in SAPC and SAHPRA online portals, ensuring timely submission of licensing applications, renewals, and regulatory notifications.
• Proficiency in pharmacovigilance reporting systems, supporting the receipt, documentation, and onward reporting of Adverse Drug Reactions.
• Strong working knowledge of warehouse inventory systems, applied to the control of pharmaceutical stock, scheduled products, and medical devices.

Skills Requirements

• Strong communication skills to liaise effectively with regulatory bodies, clients, and internal teams.
• Proven problem‑solving skills to identify corrective actions and improvement opportunities.
• Solid organisational skills to coordinate QMS meetings, audits, and training schedules.
• Attention to detail to ensure accurate documentation, reporting, and compliance with licensing requirements.
• Analytical skills to assess audit findings, CAPAs, and pharmacovigilance data.
• Leadership skills to supervise wholesale pharmacy operations and ensure personnel competency.
• Intermediate proficiency in Microsoft Office Suite, with the ability to prepare compliance reports, maintain audit records, and create structured documentation in Word, Excel, and Outlook.
• Advanced proficiency in Quality Management System software, enabling accurate tracking of ISO compliance, corrective actions, and audit close‑outs.
• Proficiency in SAPC and SAHPRA online portals, ensuring timely submission of licensing applications, renewals, and regulatory notifications.
• Proficiency in pharmacovigilance reporting systems, supporting the receipt, documentation, and onward reporting of Adverse Drug Reactions.

Work Location: In person