REGULATORY AFFAIRS / QUALITY ASSURANCE PHARMACIST [ANIMAL SCIENCES] - Centurion
Futurelink Global Recruitment
Our Client, based in Centurion, is looking for a Regulatory Affairs/Quality Assurance Pharmacist to join their team. Regulatory Affairs (RA): Submit new dossiers for health products to authorities in South Africa and other markets (Namibia, Botswana, Zambia, etc.). Liaise with contract manufacturers and research organizations for data generation for new product registrations or variations. Maintain dossiers in line with current legislation and submit variations as required, including updating to electronic CTD format. Review and approve artwork and promotional material in compliance with legislation; submit to authorities as needed. Renew all registrations according to the renewal cycle. Perform administrative duties, including database maintenance. Quality Assurance (QA): Assist QA Manager with artwork review and quality management system for Act 101 products. Integrate ISO 13485 medical devices into the QMS. Co-audit local audits, generate/review reports, and close findings via CAPA. Log and follow up on customer complaints, deviations, CAPAs, and change controls. Conduct annual product quality reviews for Act 101 products. Review ongoing stability reports, update stability logs, and notify the Responsible Pharmacist (RP) of findings. Assist with QA batch release of Act 101 products in the absence of QA Manager and RP/Deputy RP. Review and update SOPs and Technical Quality Agreements as required. Prepare for inspections, renew licenses, and assist with GMP in-house training. Act as an authorized representative for medical devices. B. Pharm degree with at least two years of experience in compilation of new dossiers and variations to SAHPRA. Experience in dealing with the Department of Agriculture on products registered under Act 36 of 1947 would be an advantage. Experience with QMS (Act 101), change control, deviations, annual product review, ongoing stability. GMP auditing/ ISO 13485 auditing experience (advantageous). Experience with self-inspection audits/ SAHPRA inspections an advantage. Ability to compile APQRs for act 101 products annually. Previous batch release of act 101 products an advantage but not mandatory. Ability to work between RA and QA.
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