Computer Systems Documentation Expert

3 days ago


Vellore, Tamil Nadu, India beBeeDocumentation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

As a Technical Documentation Specialist, you will be responsible for creating comprehensive and regulatory-compliant documentation for CSV processes. This includes translating complex technical concepts into clear, accessible language for diverse stakeholders, applying industry-specific knowledge to ensure documentation meets GxP and GAMP 5 standards, collaborating with cross-functional teams to gather inputs and feedback, drafting precise and actionable user stories reflecting functional and compliance requirements, creating and maintaining technical documentation including Validation Plans, Security Plans, VSRs, SOPs, documenting change control processes and preparing 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.

This role offers the opportunity to work on challenging projects, collaborate with a talented team, and develop your skills in technical documentation and communication.



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