QA CSV Specialist

vor 2 Wochen

Visp Valais, Schweiz Gi Group Vollzeit CHF 90'000 - CHF 120'000 pro Jahr

QA CSV Specialist (m/f/d)

Start: Jan 2026

Location: Visp, Valais

Contract: Temporary - 1 year

Summary:

The QA CSV Specialist plays a key role in defining and implementing industry best practices for Computer System Validation (CSV) within the framework of GAMP regulations. This position combines strategic initiatives to improve CSV processes with hands-on support for operational activities, ensuring compliance and efficiency across the site. The role reports to the Head of QA Validations and Qualifications.

Key Responsibilities:

  • Act as the QA representative and primary liaison between QA CSV and internal/external stakeholders.
  • Monitor industry regulations and trends, applying this knowledge to optimize policies and procedures for validation and lifecycle management of computerized systems (e.g., MES, DeltaV), spreadsheets, and bench-top equipment.
  • Provide expert IT guidance to management for GMP-related decisions concerning computerized systems.
  • Implement continuous improvement initiatives, local Validation Plans, and Master Plans to enhance departmental efficiency and eliminate non-value-added activities.
  • Ensure compliance with regulatory requirements (GMP Annex 11, 21 CFR Part 11, GAMP, PIC/S) throughout all system lifecycle stages—from Commissioning & Qualification (C&Q) and CSV documentation to system retirement.
  • Manage projects effectively: define scope, develop implementation plans, track progress, and proactively resolve potential roadblocks.
  • Audit projects and systems to verify that validation activities meet regulatory and corporate standards.
  • Collaborate with engineering, automation, and operations teams to assess new applications and define validation requirements.
  • Act as a conduit to the QA CSV Manager to ensure timely and accurate resolution of GMP issues.

Your Profile:

  • Bachelor's degree in Engineering, Information Technology, Natural Sciences, or a related field.
  • 5–10 years of experience in the pharmaceutical industry with advanced knowledge of CSV and system lifecycle deliverables.
  • Strong understanding of GMP regulations and GAMP principles.
  • Proven project management skills with the ability to anticipate challenges and deliver solutions.
  • Excellent communication and stakeholder management abilities.
  • Language: English required; German is an advantage.
  • Hybrid work option: up to 2 days home office per week.

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