Qualification / Validation / Metrology Manager F/M - Permanent contract

AGUETTANT is a family-owned pharmaceutical company dedicated to the development, manufacture and marketing of pharmaceutical products.

A recognised European player, AGUETTANT puts its expertise at the service of medical progress and innovation to design the therapeutic solutions of tomorrow.

On the French market, nearly 3,000 customers in the hospital sector place their trust in AGUETTANT.

Joining us means joining a company on a human scale, with teams entirely dedicated to the satisfaction of healthcare professionals.

It also means joining a company that welcomes people with diverse profiles and backgrounds who share enthusiasm, commitment and a taste for teamwork and cross-functional projects.

At Aguettant Mouvaux, where you will contribute to the transformation of the site, we are looking for a:

Qualification / Validation / Metrology Manager F/M - Permanent contract

Reporting to the Quality Director, you will work with your team of 5 people and with the departments that may be involved in the qualification / validation of equipment, processes and systems.

Your duties will be as follows:

• Define and enforce the validation policy for processes, software, cleaning processes and test methods, as well as equipment qualification and the management of the site's metrology
• Coordinate, plan and monitor validation, qualification and metrology activities with your team
• Be responsible for the Validation Master Plan and keep it up to date
• Approve the protocols and reports relating to validations and qualifications, and update the validation plan
• Provide expertise on the site's change control assessments
• Take part in projects to ensure that the various qualification and validation stages are completed
• Take part in and provide expertise during regulatory inspections and customer quality audits
• Ensure that qualifications, validations and metrology are consistent with the Aguettant Group

You hold a five-year higher education degree (Bac +5) or a pharmacy degree, and you have knowledge of the standards relating to validation and qualification in the medicinal products and medical devices industry (GMP, ISO 13485 / 21 CFR Part 820 / 21 CFR Part 11 for computerised and automated systems).

You have at least 5 to 10 years' experience in a similar role, knowledge of GMP Annex 1 and proven management experience.

Rigorous, organised and autonomous, you will be able to carry out the duties of the role successfully.

An effective communicator both orally and in writing, you have the ability to analyse and synthesise information, you value team spirit and you are open-minded.

Fluent English (spoken and written) is required for this position.