Validation Documentation Specialist

1 day ago

Kozhikode, Kerala, India beBeeDocumentation Full time ₹ 12,00,000 - ₹ 16,00,000
Job Overview

We are seeking a skilled Technical Writer to develop comprehensive documentation for CSV processes, ensuring compliance with GxP and GAMP 5 standards.

  • Develop detailed validation plans, security plans, VSRs, SOPs, and CAPA reports.
  • Translate complex technical concepts into clear language for diverse stakeholders.
  • Collaborate with cross-functional teams to gather inputs and feedback.
Requirements

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.
Responsibilities

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.

Technical Skills:

  • Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms.
Professional Experience

Preferred Qualifications:

  • Minimum 5+ years of experience as a technical writer in the pharmaceutical or life sciences domain.

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