Pharmaceutical Documentation Specialist

3 days ago


Surat, Gujarat, India beBeeData Full time ₹ 11,21,000 - ₹ 15,49,000
Job Title

Computer Validation Engineer is a critical role that demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices.

The ideal candidate will have a Bachelor's degree in computer science or related field with at least 5+ years of experience as a technical writer in the pharmaceutical or life sciences domain. They should have a strong understanding of CSV principles, GAMP guidelines, and regulatory frameworks.

  • 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.
    • 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 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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