CSV Documentation Expert

5 hours ago

Mumbai, Maharashtra, India beBeeDocumentation Full time ₹ 20,00,000 - ₹ 25,00,000
Pharmaceutical Documentation Specialist

We are seeking a highly skilled and detail-oriented professional to develop comprehensive documentation for CSV processes.

Key Responsibilities:

  • Develop regulatory-compliant documentation for CSV processes.
  • Translate complex technical concepts into clear, accessible language.
  • 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.

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.

The Ideal Candidate:

We are looking for a motivated individual who can excel in this role by combining their technical expertise with excellent communication skills.

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