Quality Assurance Officer (CMC)

Skills

Job Specifications

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 a QA-CMC Consultant to support quality oversight of pharmaceutical product development projects (in-house and subcontracted), with a focus on CMC (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 & French
Agile, pragmatic, proactive, and solution-oriented.
Rigorous, organized, and autonomous.

qa, quality, assurance, cmc, analytical, development, process, GMP, annex, pharmacist, engineer, sterile, sterility, documentation

About the Company

RBW Consulting is a proudly B Corp certified life sciences recruitment & search consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We've created a culture rooted in support, transparency and mutua... Know more

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