Computer Systems Documentation Specialist

1 week ago


Belgaum, Karnataka, India beBeeTechnical Full time ₹ 18,00,000 - ₹ 21,00,000

We are seeking a skilled professional to fill a critical role in our organization. The ideal candidate will be proficient in documenting CSV processes and have expertise in stakeholder management, user story writing, and technical documentation.


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.

Required Skills and 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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