QA Expert
vor 10 Stunden
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.
TasksDevelop 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.
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.
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
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