Quality Assurance Specialist for GMP-Regulated Environments

vor 5 Stunden


Basel, Basel-Stadt, Schweiz Aequor Consulting GmbH Vollzeit

About the Role

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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.

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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.">
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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.">
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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">
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About Us

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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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