CSV Documentation Specialist

3 days ago


Vijayawada, Andhra Pradesh, India beBeeTechnical Full time ₹ 25,00,000 - ₹ 30,00,000
Job Title: CSV Technical Writer

We are seeking a skilled professional to fill the role of a CSV Technical Writer.

  • This position requires strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices.
About the Role

The successful candidate will be responsible for developing comprehensive and regulatory-compliant documentation for CSV processes.

Main Responsibilities

  • Translate complex technical concepts into clear 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 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

To be considered for this position, candidates must possess:

  • A 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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