von: Aequor Consulting GmbH | Ort: Basel
N: AequorConsultingGmbH
N: AequorConsultingGmbH
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
N: AequorConsultingGmbH