QA Expert Senior QA Specialist Instrument Qualification mfd
QA Expert Senior QA Specialist Instrument Qualification mfd
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Salary Not Disclosed
1 Vacancy
Job Description
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 topquality standards and pioneering solutions. Join a team that pushes the boundaries of science and sets global benchmarks.
Tasks
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 requalification.
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 GMPregulated 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 / 40hour workweek
Coverage of certification costs
RekaCard with a 20% discount on up to CHF 2400
CHF 400 contribution towards a fitness subscription
Employment Type
Full Time
