QA Expert / Senior QA Specialist Instrument Qualification

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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