System Validation Specialist

22 hours ago

Madurai, Tamil Nadu, India beBeeCsvProfessional Full time ₹ 6,00,000 - ₹ 12,00,000

Job Overview:

We are seeking a skilled CSV Professional to develop, execute, and maintain validation protocols and documentation. This role is responsible for ensuring compliance with regulatory standards within the pharmaceutical and healthcare domains.

Key Responsibilities:
  • CSV Protocol Development: Create and maintain Computer System Validation (CSV) protocols and reports in compliance with FDA, EMA, and other regulatory requirements.
  • Collaboration and Documentation: Work with cross-functional teams to deliver high-quality CSV documentation on time.
  • User Manual Creation: Prepare and update user manuals, SOPs, and other technical documentation related to CSV processes.
  • CSV Activities Execution: Conduct risk assessments, validation testing, and documentation review for CSV activities.
  • Audit Support: Provide relevant CSV documentation and participate in audit response efforts during inspections.
  • Regulatory Updates: Stay updated with evolving industry regulations and ensure company practices remain aligned with current best practices.
  • Training and Development: Train internal teams and stakeholders on CSV processes and documentation expectations.
  • Process Improvement: Drive continuous improvement efforts to enhance CSV processes and document efficiency.
  • Record Maintenance: Maintain accurate records and validation documentation for all CSV-related activities and projects.
Requirements:
  • Education: Bachelor's degree in Computer Science, Engineering, or a related field.
  • Experience: Proven experience in CSV within regulated industries like pharmaceuticals or healthcare.
  • Compliance Knowledge: Strong understanding of GxP compliance, FDA, EMA guidelines, and related industry standards.
  • Communication Skills: Exceptional communication skills with the ability to produce clear, concise, and structured documentation.
  • Analytical Skills: Detail-oriented, with excellent analytical and problem-solving skills.
  • Collaboration: Capable of working independently as well as collaboratively in a team environment.

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