CSV Specialist
3 days ago
We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and inspections, and provide expert guidance on CSV processes. This position plays a key role in maintaining the quality and compliance of our IT systems, especially within the pharmaceutical and healthcare domains.
Success in this position means delivering high-quality validation documentation, ensuring timely execution of validation tasks, and maintaining strong alignment with industry standards. The role also involves on-site or remote validation execution, as per client requirements, making flexibility and communication critical to success.
- Develop and maintain Computer System Validation (CSV) protocols and reports in compliance with FDA, EMA, and other regulatory requirements.
- Collaborate with cross-functional teams to ensure timely delivery of CSV documentation with high quality standards.
- 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.
- Maintain accurate records and validation documentation for all CSV-related activities and projects.
- Provide expert CSV guidance to internal departments and stakeholders as required.
- Perform validation executions either remotely or through on-site visits, depending on client requirements.
- Bachelor’s degree in Computer Science, Engineering, or a related field.
- Proven experience in CSV within regulated industries like pharmaceuticals or healthcare.
- Strong understanding of GxP compliance, FDA, EMA guidelines, and related industry standards.
- Exceptional communication skills with the ability to produce clear, concise, and structured documentation.
- Detail-oriented, with excellent analytical and problem-solving skills.
- Capable of working independently as well as collaboratively in a team environment.
- Flexibility to travel for client visits or perform remote validation execution as needed.
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