Pharmaceutical Industry Documentation Specialist

2 days ago


Thrissur, Kerala, India beBeeCsvWriter Full time ₹ 10,00,000 - ₹ 15,00,000

We are seeking a highly skilled and detail-oriented CSV Technical Writer to join our team. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices.

Key Responsibilities:

Document Development:

• 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.

Collaboration and Communication:

• Collaborate with cross-functional teams to gather inputs and feedback.

• Draft precise and actionable user stories reflecting functional and compliance requirements.

Technical Documentation:

• Create and maintain technical documentation including Validation Plans, Security Plans, VSRs, SOPs.

• Document change control processes and prepare CAPA reports.

Qualifications and Experience:

• 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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