Senior Qualifying Specialist

vor 2 Wochen


Visp, Schweiz Randstad Vollzeit

Jobdescription Location: Switzerland (100% on-site)Contract type: Full-timeLanguage: German (mandatory); English a strong plus The roleJoin a growing pharmaceutical site as a CQV Engineer owning validation activities for equipment, systems and facilities. You’ll coordinate installations, author and execute IQ/OQ/PQ protocols, and deliver audit-ready documentation in line with cGMP/GxP and internal procedures. What you’ll doPlan and coordinate CQV for facilities & utilities (e.g., HVAC, clean/black utilities) and production equipment. Author, review, execute and report IQ/IOQ/OQ/PQ protocols and related documentation. Produce and maintain validation deliverables: URS, DQ, FMEA, Risk Assessments, FAT, SAT, and final reports. Drive gap analyses and continuous improvement across the validation lifecycle; apply lessons learned and regulatory updates. Perform Quality Systems activities: Document Management, Change Control, Non-conformities/Deviations, CAPA; write/revise procedures (SOPs/WIs). Support Engineering on validation, re-qualification and maintenance plans; ensure operational readiness of roll-outs. What you bringBachelor’s degree (or higher) in a science/technical field (Biotech, Biochem, Engineering or related). 5+ years validation experience in the pharma/biotech industry. Hands-on with IQ/OQ/PQ and validation packages (URS/DQ/FMEA/RA, FAT/SAT). Strong cGMP/GxP knowledge and technical writing skills; rigorous documentation and reporting. Proven ability to work cross-functionally and manage timelines across multiple stakeholders. German fluency (mandatory); English a strong plus. Organized, solution-oriented, and comfortable working on-site. How to apply: Send your CV highlighting IQ/OQ/PQ executions, facilities/utilities scope, and examples of Change Control/CAPA you’ve led.



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