QA Expert / Senior QA Specialist Instrument Qualification, DPS 80-100%

Requirements

• 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
• About Lonza
• Ready to shape the future of life sciences?

Additional Information

The actual location of this job is in Basel Stücki, Switzerland. For our successful Drug Product Services (DPS) focused branch located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the QA Expert/Senior QA Specialist Instrument Qualification position. What you will get: An agile career and a dynamic work culture An inclusive and ethical workplace Compensation programs that recognize high performance What will you do: 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

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