
Data Validation Specialist
3 days ago
We are seeking a skilled and detail-oriented professional to fill this challenging role.
The ideal candidate will have extensive experience with computer system validation protocols, regulatory standards, and documentation management. This position plays a key role in maintaining the quality and compliance of our IT systems, especially within the pharmaceutical and healthcare domains.
Main Responsibilities:- Develop and maintain Computer System Validation (CSV) protocols and reports that adhere to 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 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.
- Maintain accurate records and validation documentation for all CSV-related activities and projects.
- Provide expert guidance on CSV processes and procedures as required.
This is an excellent opportunity for someone who wants to work in a dynamic environment and contribute to the development of our organization's systems.
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