QA Expert / Senior QA Specialist Instrument Qualification (Ref.Nr. KR3243)

BRINE SA has been placing top specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.

BRINE SA is looking for experienced QA Expert / Senior QA Specialist Instrument Qualification for our client in Basel.

Job Purpose/ Role:

• 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;
• acts as first contact concerning equipment qualification document life cycle management; e.g. approval of instrument SOPs, qualification protocols and reports
• acts as first contact concerning compliance issues for equipment qualification in shared global systems (e.g. LIMS, DMS, SAP, Trackwise)
• Supervises and executes compliance activities like GMP status and trending of equipment qualification/re-qualification in relation to supplier qualification, changes, non-conformities, CAPAs, document management;
• Ensures the proper qualification of equipment supplier /services by supervising adherence to quality agreements and audit observations
• Tracking GMP status of equipment/instruments/computerized-systems
• Performs other duties as assigned