QA Expert / Senior QA Specialist Instrument Qualification (Ref.Nr. KR3243)
We are looking for a person who can:
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 an 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.
Minimum Requirements:
* Excellent knowledge in English mandatory (oral and written).
* Several years of experience as Specialist Instrument Qualification.
* Comfortable working under tight deadlines and with demanding quality.
Language: Fluent English (oral and written), German of advantage.
You’ll receive further information at an interview.
Please send your CV ASAP in Word format to BRINE SA: hrs@brine.ch
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