QA Expert / Senior QA Specialist Instrument Qualification

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16445en
  1. Contract
  2. English
  3. Associate
  4. Research & Development
  5. Basel
  6. Healthcare & Life Sciences

Skills

QA, Pharma, Biotech, GMP, Analytical Instruments

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On behalf of our client, we are seeking a detail-oriented QA Expert / Senior QA Specialist Instrument Qualification to join their team in Basel. This role is critical in ensuring the qualification and compliance of equipment, instruments, and computerized systems within a GMP-regulated environment.

Location: Basel, Switzerland
Contract Type: Contract
Duration: 3 months, extension possible
Start Date: ASAP
Workload: 100%

Your Responsibilities:
• Oversee and maintain the Equipment Qualification System within DPS.
• Ensure proper qualification of equipment/instruments/computerized systems in adherence to VMP(s) and GMP requirements.
• Act as the primary QA contact for equipment qualification, maintenance, and document lifecycle management, including approval of instrument SOPs, qualification protocols, and
reports.
• Serve as the main point of contact for compliance issues related to shared global systems such as LIMS, DMS, SAP, and Trackwise.
• Supervise and execute compliance activities, including GMP status tracking, trending of equipment qualification/re-qualification, and addressing supplier qualifications, changes,
non-conformities, and CAPAs.
• Ensure adherence to quality agreements and resolution of audit observations for equipment suppliers and services.
• Track GMP status of equipment/instruments/computerized systems and ensure continuous compliance.
• Perform additional duties as assigned.

Your Background:
• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or a related discipline).
• Experience in equipment qualification and maintenance within a GMP-regulated environment.
• Familiarity with global compliance systems such as LIMS, SAP, Trackwise, and DMS.
• Strong organizational skills with the ability to handle multiple compliance activities.
• Fluent in English (mandatory); additional languages are a plus.

What’s on Offer:
• An opportunity to contribute to ensuring the quality and compliance of critical systems within a leading healthcare organization.
• A collaborative and innovative work environment.
• Opportunities for career development and professional growth.

If you are passionate about quality assurance and have a strong understanding of GMP compliance, we look forward to receiving your application.

For more information, please contact Veronika von Mentzer, Recruiter, at veronika.nakev@swisslinx.com.

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