Qualification Manager F/M

il y a 2 semaines

Lyon, Auvergne-Rhône-Alpes, France Audensiel Temps plein

Audensiel Healthcare: A Young Innovative Company

Audensiel Healthcare, a young and 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 Qualification/Confirmed Validation Manager.

Your Missions

You will support the project team to:

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

Your Profile

Expected skills:

  • Sense of teamwork and management of a multidisciplinary qualification and metrology team
  • Quality writing skills
  • Autonomy, availability, good interpersonal skills
  • Ability to integrate and adapt
  • Mastering of English for interacting with suppliers and clients

Degree from an Engineering School, equivalent to bac+5, oriented towards quality management, pharmaceutical quality, risk management quality and pharmaceutical process engineering, you justify a minimum of 4 years of experience in similar functions on a pharmaceutical production site, ideally acquired on utilities (HVAC, purified water, EPPI) and production equipment (autoclave, incubator, filler, tanks).

You want to join our Lab of Excellence that values its collaborators through a proximity management and a network of experts: Come and meet us to participate in the development of our strategy

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