QA Expert / Senior QA Specialist Instrument Qualification
Auf einen Blick
- Veröffentlicht:10 Januar 2025
- Pensum:100%
- Vertragsart:Temporär
- Sprache:Englisch (Fliessend)
- Arbeitsort:Basel
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 Write an email.
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 Write an email.
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