Global Quality Specialist

  • Freelance
  • Pharmaceutical

For one of our clients, a top 5 pharmaceutical global player, we need to find a Consultant QA for a period of minimum 12 months.

Vacancy information

  • Drug substance and drug product batch disposition (release/reject decision), 
  • Product certification and release by the EU Qualified Person, and audit of internal GMP systems/processes and suppliers/third party contractors
  • Assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections

Principal Objective of the Position: Provides support to Qualified Person (QP) for R&D supplies shipped through EU Central Warehouse (EUWH) and provides QA support to CSO R&D Logistics.

Key Responsibilities and Major Duties: 

  • Compiles Qualified Person batch release dossiers
  • Supports Packaging & Labeling activities performed at EUWH
  • Provides Quality Assurance support in the Use Date Extension process
  • Provides Quality Assurance support (GMP/GDP guidance and training) for CSO R&D Logistics

...

Requirements information

Wanted : Experience in QA, specific formation is foreseen by the client.

Luc Decat

Vacancy ID: 267

Managing Partner

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