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CSV Subject Matter Expert
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Location | Belgium |
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Job Type | Contract |
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Rate | €70 - €90 per hour |
We are seeking an experienced CSV Subject Matter Expert (SME) to join our pharmaceutical client in Belgium. The ideal candidate will have a strong background in Computer System Validation (CSV) with a focus on automated and process equipment, as well as ancillary systems. This is an onsite role that requires hands-on experience in CSV validation tasks, ensuring compliance with regulatory standards.
Responsibilities
Key Responsibilities:
- Perform CSV validation activities for automated and process equipment, and ancillary systems.
- Develop and review validation documentation, including URS, FRS, IQ, OQ, PQ, and validation plans.
- Collaborate with cross-functional teams to ensure validation requirements are met.
- Provide expertise in regulatory compliance related to CSV in the pharmaceutical industry.
- Troubleshoot and resolve validation issues as they arise.
Requirements
Requirements:
- Proven experience in CSV validation for automated and process equipment.
- Strong understanding of GxP, FDA, and EMA guidelines.
- Ability to work onsite in Belgium.
- Excellent documentation and communication skills.
- Fluency in English; knowledge of French is a plus.
Apply
If this position interests you, and you would like to learn more or explore other available jobs that could also match your skill set, please apply today or email garyd@blackfieldassociates.com