Beschreibung
Instrument Qualification ExpertDuration: six months initially
Location: Basel
Key responsibilities:
- Develop and write IQ/OQ and PQ documents, validation plans/reports and other qualification relevant documentation.
- Install, qualify and maintain instruments for DP Physico-Chemical QC in close alignment with current best practices and regulations.
- Review and approve laboratory systems related reports as required following applicable SOPs and all current documentation practices.
- Ensure compliance of laboratory systems according to cGMP, following applicable SOPs, current best practices and international guidelines as well as current documentation practices.
- Ensure proper maintenance of equipment, safety and health protection following lab and safety instructions and all cGMP regulations
Key requirements:
- Experience in instrument qualification and/or computer system validation of analytic instruments and associated applications in pharmaceutical industry.
- Applied knowledge of the regulatory requirements ( 21 CFR Part 11, GAMP5, etc.).
- Good working knowledge in relevant analytic techniques and available equipment and good working knowledge of GMP compliant documentation.
- Good, interpretation and documentation of results and excellent understanding of relevant regulations and documentation requirements.
- Excellent knowledge of written and spoken English (no German required)
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.