QA Computer System Validation Contractor
A Freelance CSV specialist is needed to support the QA Engineering department in ensuring that all computer system validation (CSV) regulatory and procedural requirements are met throughout the full system lifecycle, including concept, project, operational, and retirement phases. The role will focus on manufacturing automation systems, providing expertise in reviewing and approving CSV documentation, advising on new or upgraded systems, addressing deviations, and ensuring compliance with cGMP standards and internal policies.
Specific Services
- Review and approveCSV documentation and records, including:
- SOPs, User Requirements, Impact/Risk Analyses
- Test Plans, Test Scripts
- Change Controls, CAPAs
- Participate in engineering teams for the introduction of new or upgraded systems and processes.
- Provide advice and support for CSV activities, ensuring cGMP compliance.
- Address and follow up on deviations during CSV execution.
- Communicate status updates (quality, compliance, planning) to the QA Qualification team.
Profile Requirements
Knowledge & Experience
- Background in the chemical and/or pharmaceutical industry with focus on CSV for manufacturing automation systems.
- Strong knowledge of cGMP regulations and guidelines.
- Ability to translate technical information into clear, accessible language across all organizational levels.
- Skilled at assessing urgency, criticality, and impact of decisions.
- Proven ability to multi‑task across multiple projects.
- Capable of working independently and within cross‑functional teams.
- Strong communication skills.
- Fluent in English and Dutch (written and spoken).
Specific System Know‑How
- Manufacturing automation systems (e.g., DeltaV)
- Problem report/change request systems (e.g., Comet)
- Document management systems (e.g., TruVault)
- Test tools (e.g., Kneat)
FAQs
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