Data Documentation Specialist

3 days ago

Madurai, Tamil Nadu, India beBeeCsv Full time ₹ 18,00,000 - ₹ 22,00,000
Validation Specialist

We are seeking a detail-oriented technical professional to join our team at acl-digital.

  • Develop comprehensive and regulatory-compliant documentation for CSV processes, ensuring accuracy and precision.
  • Translate complex technical concepts into clear, accessible language for diverse stakeholders, fostering effective communication.
  • Apply industry-specific knowledge to ensure documentation meets GxP and GAMP 5 standards, maintaining compliance.
  • Collaborate with cross-functional teams to gather inputs and feedback, driving project success.
  • Draft precise and actionable user stories reflecting functional and compliance requirements, facilitating stakeholder engagement.
  • Create and maintain technical documentation, including Validation Plans, Security Plans, VSRs, SOPs, to support quality management.
  • Document change control processes and prepare CAPA reports, ensuring transparency and accountability.
Qualifications:

  • Bachelor's degree in computer science, Life Sciences, or related field (Master's preferred), demonstrating academic excellence.
  • Minimum 5+ years of experience as a technical writer in the pharmaceutical or life sciences domain, showcasing expertise.
  • Strong understanding of CSV principles, GAMP guidelines, and regulatory frameworks, enabling informed decision-making.
  • Excellent writing, editing, and stakeholder engagement skills, promoting effective collaboration.
  • Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms, enhancing technical capabilities.

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