QA/RA Pharmacist
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.
Duties & Responsibilities
- 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.
Desired Experience & Qualification
- 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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