Senior Pharmaceutical Documentation Specialist

2 days ago

Alwar, Rajasthan, India beBeeDataAnalysis Full time ₹ 20,00,000 - ₹ 25,00,000
Job Description:

We are seeking a highly skilled and detail-oriented technical writer to join our organization. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry.

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.
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.

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