Senior CSV Documentation Specialist

20 hours ago

Nagpur, Maharashtra, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000

We are currently seeking a highly skilled Technical Writer with expertise in Computer System Validation (CSV) to deliver comprehensive and regulatory-compliant documentation.

Job Description:

The ideal candidate will have strong documentation capabilities, effective communication skills, and deep knowledge of the pharmaceutical industry and CSV practices. They will be proficient in stakeholder management, user story writing, and technical documentation including validation plans, security plans, VSRs, SOPs, change management, and CAPA.

Key Responsibilities:
  • Develop detailed and regulatory-compliant documentation for CSV processes.
  • Translate complex technical concepts into clear, concise 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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