QA Expert / Senior QA Specialist Instrument Qualification (m/f/d)
Aequor Consulting GmbH
- 1/13/2025
- 80 - 100%
- Position with responsibilities
- Unlimited employment
Aequor Consulting GmbH - das sind wir! Ein junges, dynamisches und motiviertes Team mit dem Ziel, Unternehmen und Talente zusammenzubringen. Unsere Stärken (und somit unsere Haupttätigkeiten) liegen in der Personalvermittlung und im Personalverleih. Gerne übernehmen wir für Sie auch den gesamten Rekrutierungsprozess als Exklusivmandat. Bei grossen oder internationalen Projekten können wir auf die Unterstützung von über 4‘000 Kolleginnen und Kollegen aus dem Mutterhaus, der Aequor Technologies Ltd., zählen.
Wir unterstützen Sie gerne gemäss unserem Motto: „Wir hören zu. Wir setzen es um.“
QA Expert / Senior QA Specialist Instrument Qualification (m/f/d)
For one of our renowned clients in the pharmaceutical and life sciences industry, we are looking for a dedicated and qualified QA Expert / Senior QA Specialist Instrument Qualification (m/f/d) in Basel. Our client is known for innovation, top-quality standards, and pioneering solutions. Join a team that pushes the boundaries of science and sets global benchmarks.
Responsibilities
- Develop and maintain the Equipment Qualification System at DPS.
- Ensure proper qualification of equipment, instruments, and computerized systems by adhering to the applicable Validation Master Plans (VMPs).
- Act as the primary contact for equipment qualification and maintenance within QA.
- Manage the lifecycle of equipment qualification documents, including approval of SOPs, qualification protocols, and reports.
- Address compliance issues related to equipment qualification in shared global systems such as LIMS, DMS, SAP, and Trackwise.
- Oversee and execute compliance activities, including monitoring and trending GMP status of equipment qualification and re-qualification.
- Ensure proper qualification of equipment suppliers and services by supervising adherence to quality agreements and audit observations.
- Track the GMP status of equipment, instruments, and computerized systems.
- Perform additional duties as assigned.
Requirements
- Proven experience in equipment qualification and maintenance in a GMP-regulated environment.
- Strong understanding of compliance requirements for global systems such as LIMS, DMS, SAP, and Trackwise.
- Proficient in developing and managing qualification documents, including SOPs, protocols, and reports.
- Ability to monitor and trend GMP status and ensure adherence to quality agreements.
- Excellent organizational and analytical skills.
- Fluent in English, both written and spoken.
Benefits
- 5 weeks of vacation / 40-hour workweek
- Coverage of certification costs
- Reka-Card with a 20% discount on up to CHF 2,400
- CHF 400 contribution towards a fitness subscription