Regulatory Affairs Pharmacist Midrand - Midrand
Alec Cameron & Associates Recruitment Solutions
A pharmaceutical company and applicant for several private label brands is currently seeking an innovative QA/RA pharmacist, passionate about complementary medicines, and will be based in Midrand. The candidate will be responsible for product compliance and involved in new product development. Release of imported and locally manufactured products. Review and approve printed packaging materials and ensure compliance with legislation and SAHPRA guidelines. Review of current formulations, packaging and label claims and making suggestions for improvement and compliance. Responsible for new product developments – formulations, packaging, and label claims. Assist with sourcing information and documentation required for new product development, including compilation of product briefs. Review and compilation of PI's and PIL's for new and existing products. Maintain the SAHPRA 3D product list updates, and compile product dossiers for CM products. Responsible for third party manufacturers, GMP audits and inspections. Maintain the Quality Management System. Keep abreast of relevant legislation changes and attend workshops/meetings related to the industry. B. Pharm degree. Registered with SAPC as a practising Pharmacist. At least three years' regulatory experience in CM. Production experience in the CM industry would be an advantage. Skills: Good analytical and technical knowledge. Excellent research ability with attention to detail. Good organisational skills Strong interpersonal skills and able to work in a team environment. Able to work independently and with minimal supervision. Possess a high standard of quality orientation. Possess integrity and able to use initiative. Good working knowledge of e-CTD submissions (preferable)
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