QA Representative, CSV for MES

Vor 4 Tagen


Neuchâtel, Schweiz AurigaVision AG Vollzeit

Your main tasks

  • Act as Quality Validation representative for site and global project implementations
  • Provide QA support for Computerized System Validation (CSV) to ensure compliance with cGxPs and industry standards
  • Collaborate with project teams to resolve quality issues and organize QA activities
  • Ensure effective communication among project stakeholders and within QA, implementing necessary processes
  • Review and approve qualification/validation documents, including design specs, test plans, protocols, and reports
  • Evaluate and approve deviations, incidents, and changes during system qualification/validation
  • Assist with drafting and reviewing procedural documents prepared by SMEs
  • Promote compliance with data integrity and CSV requirements
  • Participate in the site’s strategic Quality operations plan and support evaluation of change controls, deviations, and risk assessments
  • Ensure EHS compliance and promote safe work practices

 Your profile

  • Minimum 5 years QA or QC experience in pharmaceuticals or regulated industries
  • Strong knowledge of cGMPs, Swiss, EU, and FDA regulations, MES, and SAP
  • Proficient in Change Control, Deviation Management, and Risk Management
  • Excellent analytical, communication, and interpersonal skills in French and English
  • Works independently and effectively in cross-functional teams
  • Strong problem-solving, risk mitigation, and critical thinking skills
  • High sense of ethics, discretion, and diplomacy
  • University degree in science preferred
  • Proficient in English and French

Sebastian Pal is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).

Full discretion is guaranteed and we will gladly answer any additional questions.



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