Data Compliance Specialist

1 week ago

Jamnagar, Gujarat, India beBeeCsv Full time ₹ 9,00,000 - ₹ 12,00,000
Job Overview

We are seeking a skilled and detail-oriented professional to assume the role of CSV Specialist.

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

Key Responsibilities:
  1. Protocol Development: Develop and maintain Computer System Validation (CSV) protocols and reports in compliance with FDA, EMA, and other regulatory requirements.
  2. Collaboration and Documentation: Collaborate with cross-functional teams to ensure timely delivery of high-quality CSV documentation.
  3. Tech Writing: Prepare and update user manuals, SOPs, and other technical documentation related to CSV processes.
  4. Validation Execution: Execute CSV activities including risk assessments, validation testing, and documentation review.
  5. Audit Support: Support audits and regulatory inspections by providing relevant CSV documentation and participating in audit response efforts.
  6. Industry Knowledge: Stay updated with evolving industry regulations and ensure company practices remain aligned with current best practices.
  7. Training and Development: Train internal teams and stakeholders on CSV processes and documentation expectations.
  8. Process Improvement: Drive continuous improvement efforts to enhance CSV processes and document efficiency.
  9. Record Keeping: Maintain accurate records and validation documentation for all CSV-related activities and projects.
  10. Expert Guidance: Provide expert CSV guidance to internal departments and stakeholders as required.

The ideal candidate will possess strong analytical skills, attention to detail, and excellent communication abilities. Prior experience in CSV or a related field is preferred but not necessary.

This is an exciting opportunity to join our team and contribute to the development of high-quality IT systems.

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