Senior CSV Validator

6 days ago

Kanpur, Uttar Pradesh, India beBeeValidation Full time ₹ 8,00,000 - ₹ 12,00,000
Computer System Validation (CSV) Specialist

This role is crucial for maintaining quality and compliance within our IT systems, particularly in the pharmaceutical and healthcare domains.

  • Develop and maintain Computer System Validation (CSV) protocols and reports that comply with FDA, EMA, and other regulatory requirements.
  • Collaborate with cross-functional teams to deliver high-quality CSV documentation on time.
  • Prepare and update user manuals, SOPs, and technical documentation related to CSV processes.

Key Responsibilities:

  1. Execute CSV activities including risk assessments, validation testing, and documentation review.
  2. Support audits and regulatory inspections by providing relevant CSV documentation.
  3. Stay updated with evolving industry regulations and ensure company practices remain aligned.
  4. Train internal teams and stakeholders on CSV processes and documentation expectations.
  5. Maintain accurate records and validation documentation for all CSV-related activities and projects.
  6. Provide expert CSV guidance to internal departments and stakeholders as required.

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, 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.
  • Flexibility to travel for client visits or perform remote validation execution as needed.

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