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1 week ago
**CSV Specialist Job Description**
Role OverviewThis role involves providing expert validation services for computer systems in the pharmaceutical and healthcare domains.
The ideal candidate will be responsible for ensuring the quality and compliance of our IT systems, focusing on delivering high-quality validation documentation and timely execution of validation tasks.
- Validation Expertise
- Develop and maintain Computer System Validation (CSV) protocols and reports in compliance with regulatory standards.
- Collaborate with cross-functional teams to ensure timely delivery of high-quality CSV documentation.
- Prepare and update user manuals, SOPs, and other technical documentation related to CSV processes.
- Execute CSV activities including risk assessments, validation testing, and documentation review.
- Support audits and regulatory inspections by providing relevant CSV documentation and participating in audit response efforts.
- Stay updated with evolving industry regulations and ensure company practices remain aligned with current best practices.
- Train internal teams and stakeholders on CSV processes and documentation expectations.
- Drive continuous improvement efforts to enhance CSV processes and document efficiency.
The successful candidate will have a strong background in CSV and excellent communication skills, enabling them to effectively collaborate with cross-functional teams.
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