Qualification Specialist
vor 2 Wochen
At GULP – experts united, we are currently seeking an experienced Qualification Specialist to join our team. As a key member of our team, you will be responsible for supporting the qualification of technical systems and QA functions in system projects. Your tasks will include reviewing system qualification and/or device qualification in accordance with internal and external specifications, as well as conducting QA reviews of periodic reviews for qualified/validated devices, laboratory equipment, IT systems, and plants.
Key Responsibilities:
- Support in the qualification of technical systems/QA function in system projects
- Review during system qualification and/or device qualification in accordance with internal and external specifications
- QA review of periodic reviews for qualified/validated devices, laboratory equipment, IT systems, and plants
- QA reviews of technical change requests and technical documents (specifications, measuring point protocols, etc.)
- Advice on qualification issues
Requirements:
- University degree in natural sciences, engineering, or computer science or a similar qualification, alternatively professional experience in the relevant field
- Experience in the qualification of devices and/or technical equipment in a GxP-regulated environment (medicinal products, medical devices, in-vitro diagnostics)
- Fluent German and good written and spoken English skills
We Offer:
- Attractive salary package with Christmas and vacation bonuses
- Extensive social benefits, including Christmas and vacation bonuses
- Up to 30 days of vacation per year
- Reimbursement of travel expenses
- Development of skills
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