Data Compliance Expert

2 weeks ago

Mysore, Karnataka, India beBeeComputer Full time ₹ 8,00,000 - ₹ 15,00,000

We are seeking a skilled and detail-oriented professional to fill the position of CSV Specialist. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards.

Responsibilities:
  • Create and maintain Computer System Validation (CSV) protocols and reports in accordance with FDA, EMA, and other regulatory requirements.
  • 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 current with evolving industry regulations and ensure best practices remain aligned with current regulations.
  • Train internal teams and stakeholders on CSV processes and documentation expectations.
  • Drive continuous improvement efforts to enhance CSV process efficiency.
  • Maintain accurate records and validation documentation for all CSV-related activities and projects.

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