Professional Validator

2 days ago

Nellore, Andhra Pradesh, India beBeeSpecialist Full time ₹ 8,00,000 - ₹ 12,00,000
Job Opportunity

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

The ideal candidate will collaborate with cross-functional teams, contribute to audits and inspections, and provide expert guidance on CSV processes.

This position plays a key role in maintaining the quality and compliance of our IT systems.

Key Responsibilities:
  1. Protocol Development: Develop and maintain Computer System Validation (CSV) protocols and reports in compliance with regulatory standards.
  2. Team Collaboration: Collaborate with cross-functional teams to ensure timely delivery of CSV documentation with high quality standards.
  3. Documentation Management: 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.

Requirements include a Bachelor's degree in Computer Science, Engineering, or a related field. The ideal candidate will have proven experience in CSV within regulated industries like pharmaceuticals or healthcare, with 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.
  • Detail-oriented, with excellent analytical and problem-solving skills.
  • Capable of working independently as well as collaboratively in a team environment.

This is an exciting opportunity to work on cutting-edge technology and be part of a dynamic team.

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