Qualification/Validation Manager F/M

Audensiel; Lyon; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Une société innovante dans le secteur pharmaceutique, Audensiel Healthcare, recherche un Manager Qualifié en Validation. Vous serez responsable de la stratégie de qualification, de la rédaction des protocoles, et de la liaison avec les départements pour assurer la conformité qualité. Saisissez l'opportunité de rejoindre une équipe dynamique au sein d'une entreprise engagée pour le bien-être de ses employés.

Qualifications

• Expérience en management de qualité et validation requise.
• Connaissance des protocoles IQ/OQ/QP et des méthodes FMEA.
• Capacité à travailler en collaboration avec des équipes interfonctionnelles.

Responsabilités

• Mettre en place la stratégie de qualification et rédiger les VP.
• Effectuer des analyses de risque et de criticité.
• Superviser les tests auprès des départements concernés.

Connaissances

Analyse des risques

Gestion de la qualité

Rédaction de protocoles

Anglais technique

Description du poste

Audensiel Healthcare, a young innovative company, was born from the desire to bring expertise and responsiveness to its customers in the Pharmaceutical, Biotechnology, and Medical Devices sectors.

Our engineering and consulting firm, a human-sized company, has the mission to contribute to the improvement of our customers' productivity through complementary business expertise: Engineering and new works, Commissioning, Qualification/Validation, Regulatory Affairs, Quality Assurance, Operational Excellence.

Proud of our values, we have been awarded the «Great Place to Work» label, which is synonymous with the well-being of our employees and our commitments to them.

As part of the development of our activities, Audensiel Healthcare is looking for a Qualification/Confirmed Validation Manager.

As an Audensiel Healthcare consultant, your missions will be to solve the problems of our main customers and to bring your know-how.

You will support the project team to:

1. Set up the qualification strategy (drafting the VP)
2. Perform risk and criticality analyses, using the FMEA method
3. Write and/or approve commissioning (FAT/SAT) and qualification protocols: IQ / OQ / QP
4. Organize tests with cross-functional departments (production, maintenance, etc.) and supervise tests
5. Write and/or approve commissioning and qualification reports: IQ / OQ / QP
6. Manage non-compliance with Quality Assurance
7. As part of TSF, travel to suppliers is expected, and a level of technical English is required