Computer Systems Validation Documentation Specialist

2 days ago


Malappuram, Kerala, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000
Technical Writer for Computer Validation

We are seeking a highly skilled and detail-oriented technical writer to develop comprehensive and regulatory-compliant documentation for CSV processes.

  • Key Responsibilities:
  • 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.

Qualifications:

  • 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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