QA CSV Specialist

vor 1 Tag

Visp Valais, Schweiz Hays Vollzeit

The
QA CSV Specialist
plays a key role in ensuring compliance and efficiency in the validation and lifecycle management of computerized systems. Reporting to the QA Validations & Qualifications Head, this position combines strategic process improvement with hands-on operational support, ensuring systems meet both regulatory requirements and business needs.

Location: Visp

Duration: 12 months (possibility of extension)

Workload: 100%

Home office: 2 days per week

Responsibilities

  • Act as QA liaison: Represent the QA department and serve as the primary contact for CSV-related matters with internal and external stakeholders.
  • Ensure compliance: Monitor evolving industry regulations (GMP Annex 11, 21 CFR Part 11, GAMP, PIC/S) and integrate best practices into local policies and procedures.
  • System validation: Oversee validation and lifecycle management of computerized systems (MES, Delta V, spreadsheets, bench-top equipment).
  • Technical guidance: Provide expert IT input to support GMP decisions on system validation and lifecycle management.
  • Continuous improvement: Develop and implement procedures, Validation Plans, and Master Plans to enhance efficiency and compliance.
  • Project leadership: Define scope, create implementation plans, track progress, and proactively address risks to keep projects on schedule.
  • Auditing: Conduct audits to ensure validation activities meet regulatory and corporate standards.
  • Cross-functional collaboration: Partner with engineering, automation, and operations to assess new applications and define validation requirements.
  • Escalation support: Act on behalf of the QA CSV Manager to ensure timely resolution of GMP issues.

Requirements

  • Education: Bachelor's degree in Engineering, Information Technologies, Natural Sciences, or related field.
  • Experience: 5–10 years in the pharmaceutical industry with advanced expertise in CSV and GMP regulations.
  • Languages: English required; German is a plus.

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