QA CSV Consultant

Vor 2 Tagen

Visp Valais, Schweiz Consultys Suisse Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

We are looking for a QA CSV Specialist to join our teams in Visp and support the Quality Assurance department in ensuring robust validation and lifecycle management of computerized systems.

Your Responsibilities

  • Serve as the primary QA CSV representative, acting as a liaison between QA and internal/external stakeholders to ensure clear alignment on CSV expectations and requirements.
  • Proactively monitor industry regulations, guidelines, and trends (GAMP, 21 CFR Part 11, Annex 11, PIC/S, etc.) and apply this knowledge to continuously optimize policies, procedures, and validation approaches.
  • Provide expert technical IT and CSV guidance to the QA CSV Manager to support GMP decisions related to system validation and lifecycle activities.
  • Lead the implementation of continuous improvement initiatives, ensuring validation processes, procedures, and master plans operate efficiently and effectively.
  • Ensure all activities throughout the system lifecycle—from Commissioning & Qualification (C&Q), CSV documentation, periodic reviews, change control, and system retirement—are compliant with regulatory requirements and internal standards.
  • Act as an experienced project manager, defining project scopes, implementation plans, timelines, and monitoring mechanisms; proactively identify risks, roadblocks, and mitigation strategies.
  • Conduct audits of projects and computerized systems to ensure all validation activities are completed appropriately and meet applicable regulations and corporate expectations.
  • Collaborate with Engineering, Automation, Operations, and other functions to evaluate new applications and determine corresponding validation requirements.
  • Act on behalf of, or serve as a conduit to, the QA CSV Manager for escalating CSV and GMP-related issues and ensuring timely, compliant resolution.

Your Profile

  • Bachelor's degree in Engineering, Information Technologies, Natural Sciences, or a related field.
  • 5–10 years of experience in the pharmaceutical industry with advanced expertise in Computer System Validation and system lifecycle management.
  • Strong knowledge of GMP Annex 11, 21 CFR Part 11, GAMP, PIC/S, and related regulatory frameworks.
  • Proven experience with process control systems (MES, DeltaV), laboratory equipment, and validated spreadsheets.
  • Demonstrated project management capability, including planning, execution, communication, and stakeholder engagement.
  • Excellent communication skills; English required, German is an advantage.
  • Ability to work in a hybrid model (up to 2 days home office).

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