Responsible Pharmacist and Regulatory Affairs/Quality Assurance Pharmacist
One of the leading Pharmaceutical Manufacturing companies has an opening for a RP/RA/ QA Pharmacist to:
- Ensure that CMO remains GMP compliant and complies with all local legislation and requirements as OER the product dossiers.
- Compiling/overseeing submission of dossiers according to annual product submission plan to SAHPRA and regional Medicines Regulatory Authorities within SADC.
- Continuous liaison with SAHPRA to ensure new product registrations are received on time to satisfy the requirement of the business
- Control the manufacturing or distribution of medicines, scheduled substances, or medical devices in terms of the provisions of the Medicines Act, 1965.
- Ensure that there is compliance with Good Pharmacy Practice as published by the Pharmacy Council.
- Ensure that no person is appointed to perform any act falling outside the scope of practice of the category in which such person is registered or which he/she is not authorised to perform in terms of the Pharmacy Act, 1974 (Act 53 of 1974).
- Report in writing any non-compliance with the Pharmacy Act to the management of such pharmacy business and furnish Pharmacy Council with a copy thereof.
- Bachelor of Pharmacy Degree
- Previous working experience in Production and Quality Assurance is advantageous.
- 5 years’ experience in a Regulatory Affairs department
Please email your CV to email@example.com with the Ref No in the subject line and if you do not hear from us within 2 weeks, please consider your application unsuccessful.