Data Validation Specialist

15 hours ago

Ajmer, Rajasthan, India beBeeDataValidation Full time ₹ 8,00,000 - ₹ 15,00,000
Job Overview

We are seeking an experienced professional to assume the role of Data Validation Specialist.

This is a pivotal position that involves developing, implementing and maintaining validation protocols and documentation to ensure compliance with regulatory standards.

The ideal candidate will work collaboratively with cross-functional teams, contribute to audits and inspections, and provide expert guidance on data validation processes.

This position plays a key role in maintaining the quality and compliance of our IT systems, particularly within the pharmaceutical and healthcare domains.

Main Responsibilities:
  1. Develop and maintain Computer System Validation (CSV) protocols and reports in accordance with FDA, EMA, and other regulatory 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 CSV 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. Maintain accurate records and validation documentation for all CSV-related activities and projects.
  7. Provide expert CSV guidance to internal departments and stakeholders as required.
Requirements and Qualifications
  • 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.
  • Excellent 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.

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