QA Officer (CMC) - Contract

​Quality Assurance (CMC) Consultant

Pharmaceutical Development

Location:Orléans, France (occasional travel possible)

Duration:6 months

Start Date:ASAP

Work Mode:Hybrid (remote work possible once established and independent)

We are seeking aQA-CMC Consultantto support quality oversight of pharmaceutical product development projects (in-house and subcontracted), with a focus onCMC (Chemical Manufacturing and Control)activities.

Key Responsibilities

• Act as QA-CMC within CMC project teams, ensuring end-to-end quality from active ingredient to investigational drug.

• Draft and update Quality Agreements.

• Review Product Specification Files and supporting documentation (protocols, stability reports, validation, etc.).

• Conduct clinical batch file reviews for release of active ingredients and investigational injectable drugs.

• Evaluate deviations, CAPAs, change controls, anomalies, and OOX.

• Lead or contribute to risk analyses supporting CMC strategy.

• Participate in due diligence activities.

Profile

• Pharmacist or engineer with 3–5 years’ experience in quality, ideally in

  pharmaceutical development

  of sterile and dry forms.

• Strong knowledge of

  GMP (Annex 1 & 13)

  and

  ICH guidelines.

• Fluent in English.

• Agile, pragmatic, proactive, and solution-oriented.

• Rigorous, organized, and autonomous.

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