QA Officer (CMC) - 6 month contract

​RBW Consulting are partnered with a leading French Pharmaceutical in their search for a QA Officer (CMC) to come on board ASAP for an initial 6 month contract. This role will be fully office based in Orleans but will become hybrid once you are up and running within the business.

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Start of mission: As soon as possible

Duration: 6 months

Location: Orléans with occasional trips possible

Languages: French & English

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The content of the consultant's mission will be as follows:

Quality monitoring of product projects in development (in-house or subcontracted development) for CMC (Chemical Manufacturing and Control) activities by:

- As a member of the CMC project team as QA-CMC, you guarantee the overall quality of pharmaceutical development activities from the Active Ingredient to the investigational drug (end to end)

- Participating in the drafting and updating of quality contracts (Quality agreement)

- Evaluating and ensuring the compliance of the deliverables and development support studies necessary for the elaboration of the drug specification files (PSF) with the quality standards in force (quality review of the Product Specification File, techniques, standards, protocols/stability reports/validation and analytical transfer, expiration, MBR, etc.) and deliverables supporting the drafting of marketing authorization files

- Conducting file reviews of clinical batches of active ingredients and investigational injectable drugs for release

- Evaluating deviations, change control, anomalies, OOX, CAPA, etc.

- Leading or contributing to the necessary risk analyses justifying the CMC development strategy

- Also participating in due diligence

The products concerned may be injectable products or dry forms.

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Profile sought:

Preferably a pharmacist/engineer with experience in sterile products and dry forms, ideally in Pharmaceutical Development

- 3 to 5 years of experience in quality and in particular in the review of clinical or commercial batch files of sterile and dry products

- Mastery of GMP (including Annex 1 and Annex 13) and ICH regulations

- Fluent in English

- Agile/solution-oriented/proactive/pragmatic/mobility

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Please apply here and Harry Henson will be in touch to discuss your application further!

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