Beschreibung
Verification Engineer / Verification Technician (m/f)
Reference: -en
Start: ASAP
Duration: 12 MM++
Main tasks:
- Translate cGxP and normative requirements (e.g. USP, Ph. Eur., ISO, ASTM) into practical lab processes (e.g. test sample management, test method validation and transfer, discrepancy management and out of specification(OOS), training, change management, complaints) including practical development, testing, implementation, documentation
- Author protocols, rationales and reports
- Support Change Control activities for Test Methods and Lab Processes
- Execute and support testing activities on medical devices/combination products within cGxP regulated or non-GxP area
- Support internal/external Quality inspections of Verification Engineering Labs and help define appropriate responses
- Support the development and completion of robust, risk-based, medical devices/combination products verification strategies
- Write & review design verification plans, protocols, reports and rationales for justifying chosen approaches (e.g. acceptance criteria, statistical sampling, time points)
- Execute test data analysis (e.g. k-value)
- Support management of unexpected events (e.g., discrepancies, complaints) for medical devices/combination products within cGxP regulated area
Main qualifications
- Technical/Engineering degree education or equivalent experience
- Process oriented and analytical thinking
- Experience in characterization of medical device/combination products or packaging is an asset
- Experience with working in Pharma or Medical Device (cGxP, QSR) or other closely-regulated environment (e.g. automotive or food industry)
- Sound knowledge of legislation, regulation, industry standards and guidance around the area of combination products and medical devices is an asset
- Fluent command of spoken/written German and English
- Good documentation skills
Main advantages:
- Pleasant working atmosphere
- Varied tasks in a renowned company
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Dominic Yves Peter
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