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QA Pharmacist

3 months ago

Midrand, South Africa iStaff Recruitment Full time
Minimum Requirements
  • Grade 12
  • BPharm degree
  • At least 6 years of experience in QC
  • Manufacturing experience
  • Knowledge of cGMP principles
  • Understanding of legislation for Manufacturing Pharmacy and regulatory processes

Duties and Responsibilities:
  • Manage product launch after successful completion of safety, efficacy, and quality testing
  • Pharmacovigilance and handle technical complaints and participate in quality system oversight.
  • Ensure third-party distribution adheres to South African quality standards
  • Facilitate document issuance and production batch release
  • Assist with third-party audits of manufacturers and labs.
  • Supporting the business by ensuring timeous review and release of batches to the market.
  • Assisting in third party audits of manufacturers and laboratories, by accompanying the MCC inspectors and Company Global Audit Team on inspections and facilitating inspection responses between the site and the auditing body.
  • Contribute to quality complaint investigations
  • Review and authorize stability data
  • Develop annual plans for internal and external quality audits.
  • Review change controls, deviations, and non-conformances
  • Review master batch documentation for accuracy.
  • Maintain retention sample storage system
  • Establish and manage a system for supplier evaluation and approval
  • Compile and review SOPs
  • Coordinate artwork for product labeling and marketing materials.
  • Assist with company GMP annual training
  • Participate in annual product reviews
  • Draft and approve technical agreements

When applying, ensure your CV is in WORD or PDF format, and not scanned. Our software will not be able to match you to positions if it is scanned, therefore you might never get feedback from us. Scanned cvs will not be considered.

Please accept your application as unsuccessful if you had no feedback within 7 days of applying. We regret that due to the high volume of applications received, we are unable to acknowledge every application. We will keep your CV on our database and match to other suitable positions, but this wont be possible if your CV was scanned. We will contact you in future should you match a different position.

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