CSV Process Expert

2 weeks ago

Coimbatore, Tamil Nadu, India beBeeCompliance Full time ₹ 10,00,000 - ₹ 16,00,000
Job Opportunity: CSV Specialist

As a highly skilled and detail-oriented professional, we are seeking an individual to excel in the role of CSV Specialist. This position plays a pivotal part in maintaining the quality and compliance of our IT systems, especially within the pharmaceutical and healthcare domains.

Key Responsibilities:
  • Develop and maintain Computer System Validation (CSV) protocols and reports in compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure timely delivery of CSV documentation with high-quality standards.
  • Prepare and update user manuals, SOPs, and other technical documentation related to CSV processes.
  • Execute CSV activities including risk assessments, validation testing, and documentation review.
  • Support audits and regulatory inspections by providing relevant CSV documentation and participating in audit response efforts.
  • Stay updated with evolving industry regulations and ensure company practices remain aligned with current best practices.
  • Train internal teams and stakeholders on CSV processes and documentation expectations.
  • Drive continuous improvement efforts to enhance CSV processes and document efficiency.
  • Maintain accurate records and validation documentation for all CSV-related activities and projects.
  • 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.

This is an exceptional opportunity for individuals who thrive in fast-paced environments and possess expertise in CSV. The ideal candidate will be up-to-date with evolving industry regulations and able to drive continuous improvement efforts.

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