Job Description

South Africa - Gauteng, Johannesburg - North (Sandton / Midrand / Diepsloot)

R750 000 - R800 000

Our Pharmaceutical client is looking for a RA/QA Pharmacist to join their Animal Health division.

Key requirements

• B. Pharm degree with at least 2 years of experience in compilation of new dossier and variations to SAHPRA
• Experience in dealing with the department of Agriculture on products registered under ACT 36 of 1947
• Experience with QMS(Act 101), change control, deviations, annual product review, ongoing stability
• GMP Auditing/ISO 13485 auditing experience would be an advantage
• Experience with self-inspection audits/SAHPRA inspections an advantage
• Ability to compile APQRs for Act 101 products annually
• Ability to work between RA and QA
• Previous batch release of Act 101 products would be an advantage

Key functions RA

• Submission of new dossiers for animal health products including registered veterinary medicines, stock remedies, farm feeds and agricultural remedies to the authorities, namely SAHPRA and the department of Agriculture in South Africa and the relevant authorities in other markets including Namibia, Botswana, Zambia and other
• Liaising with contract manufacturers and/or contract research organizations on the requirements for data generation for new product registration or for variations
• Maintenance of all dossiers in line with current legislation and submission of variations to the authorities in line with legislation based on the applicable guidelines. This includes dossier update of the Act 101 products to electronic CTD format

Key functions QA

• Assist QA Manager with Artwork review (Act 101)
• Assist QA Manager with quality management system for Act 101 (includes but not limited to SOPs, Deviations, Risk management, change control
• Assist with ISO 13485 Medical services-integrate into one QMS
• Annual products quality reviews to be carried out according to SOPs for registered Act 101 products

Measured Ability