Senior Consultant – Contamination Control Strategy / Annex 1 (H/F/X)

Description

Our client, a pharmaceutical production site (Active Pharmaceutical Ingredient – API manufacturing) based in Geel, is urgently looking for a senior freelance consultant for an assignment centered on Annex 1 and the Contamination Control Strategy (CCS). The assignment mainly consists of performing a gap assessment of the contamination control strategy against the requirements of the revised Annex 1 of the European GMP, and supporting the site in achieving compliance. Your responsibilities: Analyze existing documentation (CCS, procedures, qualifications, environmental monitoring) and identify gaps against Annex 1 Conduct a structured gap assessment and formalize findings and recommendations Propose and prioritize a corrective action plan and follow-up Work closely with the on-site Quality, Production and Engineering teams Provide regular progress reporting to stakeholders Assignment of one year or more, full-time or 4/5, with 2 to 3 days on-site per week in Geel. Prompt start requested.

Profile sought

• Freelance / independent status required
• At least 10 years of proven senior-level experience in Contamination Control Strategy / Annex 1
• Solid knowledge of pharmaceutical GMP, ideally within an API (Active Pharmaceutical Ingredient) production environment
• Experience conducting gap assessments and drafting corrective action plans
• Strong communication and collaboration skills with Quality, Production and Engineering teams
• Quick availability given the urgent nature of the assignment
• Professional-level English required