Responsible Pharmacist is a company legal appointment required by the South African Health Products Regulatory Authority (SAHPRA) for the manufacturing, warehousing, distribution, and marketing of pharmaceutical products.
The role provides regulatory, quality, and manufacturing oversight of medicinal gases to ensure compliance with current Good Manufacturing Practices (cGMP), Good Pharmacy Practice (GPP), SOPs, and applicable pharmaceutical legislation.
The key responsibilities include but are not limited to:
1. Manage all regulatory interactions with the South African Health Products Regulatory Authority (SAHPRA), including the preparation, submission, and maintenance of manufacturing licences, site licences, product registrations/dossiers, and variation applications.
2. Ensure compliance with Medicines and Related Substances Act requirements, maintain regulatory documentation, and ensure inspection readiness.
3. Monitor regulatory changes affecting medical gases and pharmaceutical manufacturing.
4. Fulfil all statutory responsibilities of the Responsible Pharmacist as defined by the South African Pharmacy Council Act.
5. Ensure the company maintains compliance with Good Pharmacy Practice (GPP) and applicable medicines legislation.
6. Maintain appropriate control over the procurement, storage, manufacture, and distribution of medicinal gases.
7. Ensure that all activities relating to medicinal products are performed in compliance with regulatory standards.
8. Establish and maintain the Quality Management System (QMS) in line with GMP requirements.
9. Ensure compliance with pharmaceutical GMP standards for manufacturing operations.
10. Oversee batch record review and approval, product release, change control, CAPA systems, deviation investigations, and risk assessments.
11. Ensure validation and qualification activities are implemented for equipment, processes, and cleaning.
12. Ensure manufacturing processes for medicinal gases, including cylinder filling, labelling, testing, storage, quality control testing, and product release processes, comply with cGMP and regulatory requirements while ensuring traceability and batch documentation integrity.
13. Lead internal and external quality audits, prepare and manage SAHPRA inspections, and implement corrective and preventive actions following audit findings.
14. Manage product quality complaints, investigations, and adverse event reporting where applicable, and risk assessments relating to manufacturing and product quality.
15. Provide GMP and regulatory training to staff, ensure competency of personnel involved in pharmaceutical manufacturing activities, and foster a culture of quality and regulatory compliance across the organisation.
