Gauteng: Responsible Pharmacist (Regulatory and Quality Assurance) posted by Air Products South Africa Limited

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. 1. Must have a Bachelor of Pharmacy Degree (BPharm) and be a registered pharmacist with the South African Pharmacy Council. 2. Eligible to act as a Responsible Pharmacist in South Africa. 3. Minimum 5 years pharmaceutical industry experience. 4. Possession of a valid drivers license and reliable personal transportation is required. 5. Open to travel as a fundamental operational requirement of the role. 6. Willing to work in a gas operations environment. 7. Proven experience in GMP-regulated manufacturing environments. 8. Experience dealing with the South African Health Products Regulatory Authority (SAHPRA), including regulatory submissions. 9. Experience in Regulatory Affairs and Quality Assurance roles, including quality audits and inspections, and QMS implementation. 10. Experience in medical gases or sterile/pharmaceutical manufacturing will be advantageous. 11. Proven experience in the manufacturing of pharmaceutical products will be advantageous. 12. Proven experience in the registration of new pharmaceutical products with the regulator will be advantageous. 13. Proven experience in conducting internal system audits and managing regulatory external auditors will be advantageous. Applications should reach the Human Resources Department by close of business, 05 June 2026.