Senior QA Specialist (Instrument Qualification) – 6285 ADA
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Senior QA Specialist (Instrument Qualification), based in Basel, Switzerland for a 3-month contract with a possible extension for another 3 months.
Main Responsibilities:
* Execute establishment and maintenance of Equipment Qualification System
* Ensure the proper qualification of equipment/instruments/computerized-systems by ensuring adherence to the corresponding VMP(s).
* Act as first contact for equipment qualification & maintenance within QA
* Act as first contact concerning equipment qualification document life cycle management, e.g. approval of instrument SOPs, qualification protocols and reports
* Act 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.
* Ensure the proper qualification of equipment supplier/services by supervising adherence to quality agreements and audit observations
* Track GMP status of equipment/instruments/computerized-systems
* Perform other duties as assigned
Qualifications and Experience:
* Relevant working/residency permit or Swiss/EU-Citizenship required.
* Bachelor or Master's degree in Engineering, Life Sciences or related field
* Experience in biotechnology or pharmaceutical environment
* Experience of working with Equipment Qualification Systems
* You are fluent in English (spoken and written)
* Knowledge of SAP, DMS and Trackwise, EMPOWER
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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