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
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