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Open nowPosted yesterday

Senior QA Specialist

job-room.ch91,426 open roles

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Visp, VS, Switzerland
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Your applicationOpen nowSenior QA Specialistjob-room.ch · Visp, VS, Switzerland
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  5. 34.2%30 days
This job: posted yesterday

job-room.ch median: 4 days open

The posting

Senior QA Specialist #

(m/f/d)

Freelance/temporary employment for a project

Visp

Start date: asap

Reference number: 896900/1

Responsibilities ###

  • Provide quality oversight for the qualification of manufacturing facilities, cleanrooms, and clean utility systems
  • Support environmental monitoring performance qualification activities and ensure compliance with GMP requirements
  • Review, analyze, and trend environmental monitoring data to identify potential risks and improvement opportunities
  • Ensure facilities, utilities, and related quality systems remain in a qualified and compliant state
  • Lead investigations of contamination events, monitoring excursions, and quality deviations
  • Support the implementation of corrective and preventive actions (CAPAs) related to contamination control
  • Collaborate with Manufacturing, Engineering, Validation, QC, and other cross-functional teams on facility and process changes
  • Provide microbiological expertise for change controls, risk assessments, and new product introductions
  • Support regulatory inspections and customer audits as a subject matter expert in pharmaceutical microbiology
  • Contribute to the continuous improvement of contamination prevention and control strategies across the site

Profile ###

  • Bachelor's degree in Microbiology, Biotechnology, Life Sciences, or a related scientific discipline
  • Solid experience in GMP-regulated pharmaceutical or biologics manufacturing environments
  • Strong knowledge of contamination control principles and microbiological quality requirements
  • Hands-on experience with cleanroom qualification, environmental monitoring, and clean utility systems
  • Experience supporting or leading investigations, deviations, CAPAs, and change controls
  • Good understanding of FDA, EMA, and other applicable GMP regulations
  • Familiarity with microbiological testing methods and monitoring programs
  • Strong analytical and problem-solving skills
  • Excellent communication and documentation skills in a regulated environment
  • Ability to work independently while effectively collaborating with cross-functional stakeholders

Benefits ###

  • Opportunity to contribute to quality and patient safety within a leading biotechnology environment
  • Exposure to complex contamination control and facility qualification projects
  • Cross-functional collaboration with Quality, Manufacturing, Engineering, and Validation teams
  • Dynamic and highly regulated GMP environment with diverse responsibilities
  • Opportunity to act as a subject matter expert in microbiology and contamination control
  • Involvement in regulatory inspections and customer audits
  • Professional development within a quality-focused organization
  • International and collaborative working environment
  • Meaningful role supporting operational excellence and compliance
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