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Qualified Person (Médicament d'innovation thérapeutique)

Catalent · Haute-Vienne, France

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Role summary

Catalent's Limoges site seeks a qualified pharmacist to oversee raw material acceptance, batch certification, and regulatory compliance for therapeutic innovation medicines. The role ensures GMP adherence and pharmaceutical oversight across fill/finish operations for injectable biologics.

What they're looking for

  • Pharmacy degree (Bac+5) with quality management specialization in pharmaceutical industry
  • 5+ years experience in similar qualified person or release role
  • Advanced knowledge of pharmaceutical regulations, quality systems, and GMP
  • Essential experience with therapeutic innovation medicines and sterile environments
  • Proficiency in English and strong analytical capabilities
  • Understanding of deviation management, non-conformity investigations, and quality inquiries

What you'll be doing

  • Validate and manage raw materials and finished product batches for client acceptance
  • Handle deviation management and quality investigations related to non-conformities
  • Communicate with clients on deviations, quality issues, and regulatory matters
  • Support audits concerning deviations and client requirements
  • Act as pharmaceutical representative on-site delegated from responsible pharmacist

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Date posted1 day ago
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