Computer System Validation (CSV) Specialist (m/f/d)

Westhouse Schweiz AG; Schweiz; Remoto; CHF 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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+).

Mansioni

• 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.

Conoscenze

Computer System Validation (CSV)

GxP environments

Data integrity (ALCOA+)

CSV/CSA methodologies

Regulatory compliance

IT quality

Descrizione del lavoro

For our client, an international company operating in a highly regulated environment, we are looking for an experienced Computer System Validation (CSV) Specialist to support IT projects and ensure compliance with applicable quality and regulatory standards.

The consultant will be responsible for coordinating validation activities, maintaining high quality standards and supporting the successful delivery of IT projects within a GxP regulated environment.

• Position: Computer System Validation (CSV) Specialist
• Start: ASAP
• Language: English (business fluent)
• Location: Remote

Your Responsibilities

• Coordinate and manage computer system validation activities throughout the IT project lifecycle.
• Develop, review and maintain validation documentation, including validation plans, test protocols and validation 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 relevant IT project documentation and system lifecycle deliverables.
• Identify, assess and elevate validation risks and quality related issues.

Your Profile

• 5+ years of professional experience in Computer System Validation (CSV), IT Quality or Quality Assurance.
• Proven experience in GxP regulated environments, preferably within the pharmaceutical or life sciences industry.
• Strong knowledge of CSV/CSA methodologies, validation processes and regulatory compliance.
• Good understanding of Data Integrity principles (ALCOA+) and IT system lifecycles.
• Experience preparing, reviewing and maintaining validation documentation.
• Familiarity with electronic validation or quality management tools.

Interested?

If you have a strong background in Computer System Validation and are interested in contributing to international IT projects within a regulated environment, we would be happy to hear from you.