Senior QA Specialist

vor 3 Stunden


Basel, Schweiz CTC Resourcing Solutions AG Vollzeit
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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