Beschreibung
Duration: 3 - 12 months, potential extensionLocation: Basel region or southern Switzerland, on site
Possible tasks:
- CQ Qualification and Documentation Management.
- Development, preparation and implementation of CQV including DQ, OQ, IQ Coordination and communication with other resources for Qualification / Documentation Management activities.
- Actively participate in the development and delivery of deliverables with respect to the relevant systems.
- Prioritize and execute tasks in a fast-paced environment.
- Interact with Site Operation / Site QA.
- Lead the assigned Team of Drug Product (DP) Ancillary Equipment and Lab Equipment.
Requirements:
- Technical degree (bachelor level) in engineering or applied science.
- + 3 years of experience in commissioning/qualification/validation in pharmaceutical/biotech industry.
- Strong knowledge of ISPE and ASTM guidelines with proven experience on large and complex projects. Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
- Knowledge in COMOS and Delta V preferred.
- Fluent written and verbal skills in English, German desirable.
- Experience in qualification of filling lines and associated equipment such as vial washers, depyrogenation tunnels, filling machines, lyophilizers, cappers and isolators.
- Or experienced in qualification of production support equipment such as autoclaves, parts washers, CIP/SIP, and temperature control equipment.
- Or experienced in OQ for process equipment (autoclaves, refrigeration, …).
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.