CSV Technical Document Specialist

1 day ago

Rajahmundry, Andhra Pradesh, India beBeeDocumentation Full time ₹ 18,24,000 - ₹ 24,36,000
Technical Documentation Specialist

Our organization seeks a highly skilled and detail-oriented technical documentation specialist to create comprehensive and regulatory-compliant documentation for CSV processes.

This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices. The ideal candidate will be proficient in stakeholder management, user story writing, and technical documentation including validation plans, security plans, VSRs, SOPs, change management, and CAPA.

  • Develop detailed and accurate technical documents reflecting functional and compliance requirements.
  • 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.
  • Create and maintain technical documentation including Validation Plans, Security Plans, VSRs, SOPs.
  • Document change control processes and prepare CAPA reports.

Key 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.

Benefits include working with a talented team and opportunities for growth and professional development.

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