Data Validation Expert

15 hours ago

Anand, Gujarat, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title: CSV Specialist

We are seeking a skilled and detail-oriented specialist to join our team in the role of CSV validation protocol developer.

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 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.

Key Skills 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.
  • Exceptional communication skills with the ability to produce clear, concise, and structured documentation.

Success in this position means delivering high-quality validation documentation, ensuring timely execution of validation tasks, and maintaining strong alignment with industry standards.

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