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QA Expert/Senior QA Specialist Instrument Qualification, DPS
Job in
4040, Basel, Kanton Basel-Landschaft, Switzerland
Listed on 2026-07-16
Listing for:
Lonza
Full Time
position Listed on 2026-07-16
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Job Description & How to Apply Below
QA Expert / Senior QA Specialist Instrument Qualification, DPS 80-100%
The actual location of this job is in Basel Stücki, Switzerland.
What you will get:- An agile career and a dynamic work culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance
- Executes establishment and maintenance of Equipment Qualification System at DPS
- Ensures the proper qualification of equipment/instruments/computerized-systems by ensuring adherence to the corresponding VMP(s)
- Acts as first contact for equipment qualification & maintenance within QA; e.g. author of overarching documents around instrument qualification, overall qualification strategy for complex systems
- Acts as first contact concerning equipment qualification document life cycle management; e.g. approval of instrument SOPs, qualification protocols and reports, periodic review documents
- Act as first contact concerning compliance issues for equipment qualification in shared global systems (e.g. LIMS, DMS, Trackwise)
- Supervises and executes compliance activities e.g non-conformities, change request, deviations, CAPAs, audit/inspection/self-inspection observations, document management; participation in audit/inspection/self-inspection
- Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans
- Bachelor/Master Degree or equivalent experience in natural sciences (e.g., Chemistry, Engineering, natural science, or related field)
- Significant experience with (computerized) lab instrument qualification, quality records, and controlled document lifecycle management in a EU and US GMP regulated environment
- Familiarity with ISPE GAMP5 Guide and USP 1058 required
- Experience in the usage of LIMS, DMS, Trackwise, SAP, ELN
- Good communication and ability to work independently in a team, proactive and dedicated attitude
- Excellent knowledge of written and spoken English
Position Requirements
10+ Years
work experience
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