Chargé(e) d’Assurance Qualité F/H

Audensiel; Île-de-France; Remote; EUR 42,000 - 52,000; Full time

Job summary

Audensiel Healthcare recrute un Responsable Assurance Qualité pour son agence en Île-de-France. Vous contribuerez à améliorer la productivité des clients par une expertise en QA et en conformité, en intervenant sur les postes de Production et les processus qualité.

Vous suivez les anomalies, assurez le support qualité en production et pilotez les CAPA, tout en garantissant une traçabilité rigoureuse des incidents dans les outils informatiques.

Qualifications

• Diplôme d'ingénieur, bac+5 ou équivalent pharmacie orienté gestion qualité, qualité du médicament, risques qualité et contrôle.

Responsibilities

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

Skills

Esprit d’équipe

Autonomie

Aptitudes relationnelles

Capacité d’adaptation

Education

Ingénieur Bac+5 ou équivalent Pharmacie orienté qualité

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

Qualities:

• Sense of teamwork


• Autonomy, availability, good interpersonal skills


• Ability to integrate and adapt

Qualifications:

• 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.