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Qualified Person – Pharmaceutical/Medical Gases

Afrox · Germiston

New
🇬🇧 English
Batch certification Quality Risk Assessment

Job description

About the role

The Qualified Person will ensure daily batch certification of all licensed medicinal products, often outside normal business hours, and support compliance across manufacturing and distribution functions.

Key responsibilities

  • Conduct prospective batch certification of licensed medicinal products on a daily basis, including after‑hours work.
  • Collaborate with Operations, Production, Transport and Supply Chain teams to guarantee GxP compliance.
  • Support the Regulatory Affairs Manager with license submissions.
  • Assist the Responsible Pharmacist in complaint review, root‑cause analysis and related training.
  • Participate in external GxP audits and regulatory inspections of licensed sites.
  • Develop and review validation documentation, including Quality Risk Assessments for new projects or changes.

Required profile

  • University degree in Chemistry, Pharmacy, Chemical Engineering or an equivalent scientific discipline.
  • 5–7 years of experience in pharmaceutical/medical gases manufacturing.
  • Knowledge of Good Manufacturing Practice (GMP) regulations for human medicinal products.
  • Knowledge of Good Distribution Practice (GDP) regulations for human medicinal products.

Required skills

  • Batch certification processes
  • GMP compliance
  • GDP compliance
  • Quality Risk Assessment methodology

What we offer

  • Career growth within a market‑leading gas and welding products company.
  • Work environment driven by integrity, compliance and ethics.
  • Opportunities to contribute to sustainable development and community impact.

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Published 6 days ago

Expires 1 month from now

16 views · 0 interested

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Afrox

Germiston