Advanced Validation Professional

21 hours ago

Thoothukudi, Tamil Nadu, India beBeeComputerSystemValidation Full time ₹ 8,00,000 - ₹ 12,00,000
Computer System Validation Specialist

We are seeking a highly skilled and detail-oriented Computer System Validation Specialist to fill this key role. The successful candidate will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards.

This position plays a vital part in maintaining the quality and compliance of our IT systems, particularly within the pharmaceutical and healthcare sectors.

Key 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 guarantee 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. Stay updated with evolving industry regulations and ensure company practices remain aligned with current best practices.
  7. Train internal teams and stakeholders on CSV processes and documentation expectations.
  8. Drive continuous improvement efforts to enhance CSV processes and document efficiency.
  9. Maintain accurate records and validation documentation for all CSV-related activities and projects.
  10. 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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