Data Validation Specialist

2 days ago

Ellore, Andhra Pradesh, India beBeeData Full time ₹ 9,00,000 - ₹ 12,00,000
Job Summary

We are looking for a detail-oriented professional to develop and maintain validation protocols and documentation to ensure compliance with regulatory standards.

This role involves collaborating with cross-functional teams, contributing to audits and inspections, and providing expert guidance on data processes.

The ideal candidate will play a key role in maintaining the quality and compliance of our IT systems, especially within regulated industries.

Key Responsibilities:
  1. Develop and maintain computer system validation (CSV) protocols and reports in compliance with FDA and EMA requirements.
  2. Collaborate with cross-functional teams to ensure timely delivery of CSV documentation with high-quality standards.
  3. Prepare and update user manuals, SOPs, and other technical documentation related to data processes.
  4. Execute CSV activities including risk assessments, validation testing, and documentation review.
  5. Support audits and regulatory inspections by providing relevant CSV documentation and participating in audit response efforts.
  6. Stay updated with evolving industry regulations and ensure company practices remain aligned with current best practices.
  7. Train internal teams and stakeholders on data processes and documentation expectations.
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 and 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.

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