Qualification Manager
il y a 2 semaines
Audensiel Healthcare: A Young Innovative Company
Audensiel Healthcare is a dynamic and innovative company that specializes in providing expertise and responsiveness to its customers in the Pharmaceutical, Biotechnology, and Medical Devices sectors.
Our Mission
We 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.
Job Description
We are seeking a Qualification/Confirmed Validation Manager to join our team. As an Audensiel Healthcare consultant, your missions will be to solve the problems of our main customers and to bring your know-how.
Key Responsibilities
- Support the project team to set up the qualification strategy and draft the VP
- Perform risk and criticality analyses using the FMEA method
- Write and/or approve commissioning and qualification protocols: IQ/OQ/QP
- Organize tests with cross-functional departments and supervise tests
- Write and/or approve commissioning and qualification reports: IQ/OQ/QP
- Manage non-compliance with Quality Assurance
Requirements
- Degree in Engineering or equivalent, with a focus on quality management, pharmaceutical quality, risk management, and process engineering
- Minimum 4 years of experience in similar functions on a pharmaceutical production site, preferably with expertise in utilities (HVAC, purified water, EPPI) and production equipment (autoclave, incubator, filler, tanks)
- Excellent communication and teamwork skills
Join Our Team
Audensiel Healthcare is a human-sized company that values its employees and offers a dynamic and challenging work environment. If you are passionate about quality and innovation, we encourage you to apply for this exciting opportunity.
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