CSV Documentation Expert

7 days ago

Lucknow, Uttar Pradesh, India beBeeValidation Full time ₹ 20,00,000 - ₹ 25,00,000
Computer Validation Specialist

We are seeking a highly skilled and detail-oriented technical professional to fill this role.

This position demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices.

Key Responsibilities:
  • Develop comprehensive and regulatory-compliant documentation for CSV processes.
  • Translate complex technical concepts into clear, accessible language for diverse stakeholders.
  • Apply industry-specific knowledge to ensure documentation meets GxP and GAMP 5 standards.
  • Collaborate with cross-functional teams to gather inputs and feedback.
  • Draft precise and actionable user stories reflecting functional and compliance requirements.
  • Create and maintain technical documentation including Validation Plans, Security Plans, VSRs, SOPs.
  • Document change control processes and prepare CAPA reports.

Requirements:

  • Bachelor's degree in computer science, Life Sciences, or related field (Master's preferred).
  • Minimum 5+ years of experience as a technical writer in the pharmaceutical or life sciences domain.
  • Strong understanding of CSV principles, GAMP guidelines, and regulatory frameworks.
  • Excellent writing, editing, and stakeholder engagement skills.
  • Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms.

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