Job Details
Employer: MPC Recruitment (PE/EL)

Regulatory Affairs Pharmacist

Port Elizabeth

Duties include:

  • To prepare and submit medicine registration applications to various regulatory authorities outside South Africa in accordance with regulatory requirements of the relevant country
  • To maintain these registration applications subsequent to registration approval
  • Promotion and execution of control activities necessary to provide product quality compliance and assurance
  • Approving or rejection of intermediates and finished products for supply to the market
  • Preparing and submitting medicine registration applications for imported and locally made products in foreign countries
  • Maintaining existing product registrations in foreign countries
  • Maintaining the international registration product list
  • Release of production batches
  • Review of batch documentation - assessment should embrace all relevant factors including production conditions, results of in-process testing, review of manufacturing, packaging and laboratory documentation and compliance with finished product specification
  • Liaise with production on queries and additional information in order to complete review and release
  • Monitoring and auditing compliance of batch books for release to regulatory requirements and in-house standards and SOP’s, and current good manufacturing practice
  • Approval and Release of third party and Intermediate products
  • Involvement in project decisions which may affect the quality of product
  • Input into factory training needs, where relevant
  • Co-ordination, checking and sign-off of Certificates of Analysis for third party manufactured products and exports
  • Transfer of released stock from quarantine to the finished goods warehouse on the SYSPRO computer system
  • Assist with amending / updating and checking amendments to batch manufacturing records where
  • possible
  • Attendance and report back at daily operations meetings and feedback at other meetings where relevant
  • Involvement in audits when required
  • From time to time, carry out other jobs within the factory/department, consistent with the grade    qualification and training of the incumbent

Please forward your CV to or alternatively apply online Ref: ND44823

Please note that if you have not received any response in 14 days your application has been unsuccessful

Candidate Requirements

Minimum Requirements:

  • B. Pharm / Dip. Pharm.
  • Registered Pharmacist with South African Pharmacy Council
  • 2-5 years would be ideal depending on the applicable experience of the incumbent
  • Previous experience in the position of a Release Pharmacist essential
Apply before Monday, October 22, 2018 - 31 Days left Companies may expire jobs at their own discretion. If you have not received a response within two weeks, your application was most likely unsuccessful.
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