QA Expert / Senior QA Specialist Instrument Qualification, DPS 80-100%
On-site · Basel, Basel-City, Switzerland
Job Summary
QA Expert/Senior QA Specialist Instrument Qualification at Lonza in Basel, Switzerland. Executes establishment and maintenance of Equipment Qualification System, ensuring proper qualification of equipment/instruments/computerized-systems; acts as first contact for equipment qualification & maintenance, including overarching documents, SOPs, qualification protocols and reports; manages document lifecycle and compliance issues (CAPAs, deviations, audits); mentors and monitors training plans to maintain competency across global systems like LIMS, DMS, Trackwise; supports an ethical, high-performance culture and collaboration across QA and GMP-regulated operations.
Required Qualifications
- Bachelor/Master Degree or equivalent experience in natural sciences or related field
- Significant experience with (computerized) lab instrument qualification
- quality records, and controlled document lifecycle management in a GMP environment
- Familiarity with ISPE GAMP5 Guide and USP 1058
- Experience with LIMS, DMS, Trackwise, SAP, ELN
- Good communication and ability to work independently in a team
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