Quality Assurance Specialist for GMP-Regulated Environments
vor 5 Stunden
About the Role
">Aequor Consulting GmbH is seeking a highly skilled Quality Assurance Specialist to join our team in Basel. As a QA Expert / Senior QA Specialist, you will be responsible for ensuring the quality and compliance of equipment, instruments, and computerized systems in a GMP-regulated environment.
">Key Responsibilities
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- Develop and maintain the Equipment Qualification System at Aequor Consulting GmbH.">
- Ensure proper qualification of equipment, instruments, and computerized systems by adhering to 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
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- 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
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- 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">
About Us
">Aequor Consulting GmbH is a renowned consulting firm in the pharmaceutical and life sciences industry, committed to innovation, top-quality standards, and pioneering solutions.
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