Quality assurance officer F/M

Audensiel; Île-de-France; On-site; EUR 42,000 - 62,000; Full time

Job summary

Audensiel Healthcare, jeune entreprise innovante, recrute un Responsable Qualité Assurance pour son agence en Île-de-France. Vous intégrerez une équipe dédiée à la qualité dans les secteurs pharmaceutique, biotechnologique et dispositifs médicaux.

Challenging mission: suivre les anomalies en production, assurer le support qualité, mener des enquêtes sur le terrain, mettre en place CAPA et garantir la traçabilité des incidents qualité dans les outils informatiques.

Qualifications

• Diplôme d'ingénieur ou équivalent bac+5 orienté management qualité.
• Expérience d'au moins 2 ans dans des fonctions similaires sur un site de production pharmaceutique, idéalement en procédés aseptiques.

Responsibilities

• Suivre les anomalies en production.
• Assurer le support qualité en production.
• Enquêter sur le terrain.
• Mettre en place CAPA et suivre leur déploiement.
• Assurer la traçabilité des incidents qualité dans les outils IT.

Skills

Esprit d'équipe

Autonomie

Disponibilité

Aptitudes interpersonnelles

Adaptabilité

Education

Bac+5 équivalent (École d'ingénieur ou Faculté de Pharmacie)

Job description

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 the productivity of our customers, 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, 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 Quality Assurance Officer for its agency in Ile-de-France.

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 in order to:

• Follow up on anomalies in Production
• Ensure Quality Support in Production
• Investigate in the field
• Set up CAPA and monitor their deployment
• Ensure good traceability of quality incidents in IT tools

• Sense of teamwork
• Autonomy, availability, good interpersonal skills
• Ability to integrate and adapt

Graduate (e) of an Engineering School, a bac + 5 equivalent or a Faculty of Pharmacy, oriented quality management, quality of the drug, quality control risks.

You have at least 2 years of experience in similar functions at a pharmaceutical production site, ideally acquired in sterile processes.

You want to join our «Lab of excellence» which values its employees through local management and a network of experts: Come and meet us and participate in the development of our strategy!

In accordance with its ethical commitment, Audensiel is committed to combating all discrimination and promoting diversity and equal opportunities.