CSV Compliance Expert
7 days ago
**Job Description:**
We are seeking a highly skilled CSV Compliance Expert to join our team at PQE Group. The successful candidate will be responsible for ensuring the integrity and compliance of our computer systems, which include laboratory systems, engineering systems, manufacturing systems, and SAP systems.
About the Role:
The CSV Compliance Expert will develop and execute comprehensive protocols and plans for various computer systems. This includes conducting risk assessments, performing thorough system assessments, and identifying potential compliance gaps.
You will also author and review validation documentation, collaborate with cross-functional teams, and stay up-to-date with evolving regulatory requirements and industry best practices.
Key Responsibilities:
- Develop and execute comprehensive protocols and plans for computer systems
- Conduct risk assessments and identify potential compliance gaps
- Perform thorough system assessments and data integrity reviews
- Author and review validation documentation
- Collaborate with cross-functional teams
- Stay abreast of regulatory requirements and industry best practices
Requirements:
- Strong understanding of CSV principles and methodologies
- In-depth knowledge of relevant regulations (21 CFR Part 11, EU Annex 11, GAMP 5)
- Proven experience in validating computer systems
- Expertise in data integrity principles (ALCOA) and their application in CSV
- Excellent written and verbal communication skills
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