GMP Documentation Writer

GMP Documentation Writer – Contract – Toulouse – Life Sciences

Our client, a global biotechnology organisation, is recruiting for a GMP Documentation Writer to join their capital project in the South of France. This new build facility will house a therapeutic protein production plant, and we are looking for a GMP Documentation Writer to help expand our client's biotech operations throughout Europe.

Responsibilities

1. Work together with the Documentation Coordinator, MSAT, Training, Compliance and QA to prepare Site SOPs, Work Instructions, OJT documentation, Forms, Lists and other work process documentation as required for site validation and qualification purposes.
2. Discuss, review, challenge and support definition and documentation.
3. Align with IT and key users and document way of working and best practices for Work Instructions.
4. Write site specific SOPs.

Qualifications & Experience

1. Bachelor’s degree in systems engineering or related field.
2. 10+ years of experience in the pharmaceutical, biotechnology or medical devices industry in business process delivery including writing process documentation, reviewing process design and process requirements documents, and translating documents into end user procedural guides, using English language.
3. Understanding of general supply chain processes and terminology; ideal candidate has warehouse experience and understanding of inventory management processes.
4. Independently walk-through process design and requirements documents to understand business processes.
5. Identify opportunities to consolidate different test scripts, process, and system transactions into one procedural document.
6. Ability to partner and collaborate cross-functionally.

If this role is of interest, please apply now.