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Regulatory Affairs Pharmacist Midrand

Regulatory Affairs Pharmacist Midrand

Alec Cameron & Associates Recruitment SolutionsMidrand, Gauteng, South Africa
30+ days ago
Job description

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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    Regulatory Pharmacist • Midrand, Gauteng, South Africa