Sterility Assurance Specialist M/F - 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 the Aguettant Mouvaux site, we are looking for a:

STERILITY ASSURANCE SPECIALIST M/F - PERMANENT CONTRACT

Reporting to the Sterility Manager, you will carry out the following duties:

• Ensure that all Sterility Assurance activities and documentation comply with pharmaceutical standards:
  • ensure compliance with GMP, including Annex 1, and with the marketing authorisations
  • implement Good Manufacturing Practice and internal procedures relating to contamination
  • contribute to the development and updating of the Contamination Control Strategy (CCS)
• Help develop the contamination control skills of site staff, together with the production and quality teams: cleanroom gowning, basics of microbiology, cleaning and disinfection
• Maintain an operational presence on the ground through visits / audits in production and in the laboratory on standard contamination control practices
• Ensure, with the teams, the effectiveness of investigations arising from contamination events or process sterility assurance deviations; you are qualified in the use of RCA (Root Cause Analysis) tools
• Coordinate periodic environmental trend analyses (ability to analyse data using statistical tools), the proposal of CAPAs and effective communication to the operational staff of the departments concerned
• Take an active part in internal and external audits and support their preparation

A pharmacist or holder of a five-year higher education degree (Bac +5) in Quality, Microbiology or a related field, you have significant experience in a similar role in microbiology or sterility assurance within the pharmaceutical industry.

You have a thorough command of GMP in demanding environments such as injectables, and at least 1 year's experience of issues related to sterility assurance and the application of GMP Annex 1.

A hands-on person, you are rigorous, curious and organised. Interpersonal skills are essential to work effectively with all your contacts.

Your interpersonal skills, persuasiveness and ability to make proposals will help you carry out the duties of this role successfully.