Remote CSV Specialist: GxP Quality & IT Validation

Westhouse Schweiz AG

Schweiz

Remote

CHF 90,000 - 130,000

Full time

3 days ago
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Job summary

Westhouse Schweiz AG is seeking an experienced Computer System Validation (CSV) Specialist to support IT projects in a highly regulated environment. Your role will coordinate validation activities, develop validation documentation, and ensure compliance with GxP standards.

The ideal candidate has 5+ years in CSV/QA, strong knowledge of regulatory requirements, and experience with ALCOA+ data integrity. This position offers remote work from Switzerland with ASAP start.

Qualifications

  • 5+ years in Computer System Validation (CSV) or IT QA.
  • Experience in GxP regulated environments (pharma or life sciences).
  • Knowledge of CSV/CSA methodologies and data integrity (ALCOA+).

Responsibilities

  • Coordinate and manage computer system validation activities across IT project lifecycles.
  • Develop, review and maintain validation documentation (plans, protocols, reports).
  • Ensure compliance with GxP regulations, CSV/CSA methodologies and internal quality standards.
  • Support IT project teams in applying validation processes and regulatory requirements.
  • Review and approve IT project documentation and system lifecycle deliverables.
  • Identify, assess and mitigate validation risks and quality issues.

Skills

Computer System Validation (CSV)
GxP environments
Data integrity (ALCOA+)
CSV/CSA methodologies
Regulatory compliance
IT quality

Job description

Westhouse Schweiz AG is seeking an experienced Computer System Validation (CSV) Specialist to support IT projects in a highly regulated environment. Your role will coordinate validation activities, develop validation documentation, and ensure compliance with GxP standards.

The ideal candidate has 5+ years in CSV/QA, strong knowledge of regulatory requirements, and experience with ALCOA+ data integrity. This position offers remote work from Switzerland with ASAP start.

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