Senior Validation Specialist

3 days ago


Mysore, Karnataka, India beBeeDataIntegration Full time ₹ 10,00,000 - ₹ 15,00,000
Senior Validation Specialist Role Overview

We are seeking a skilled and detail-oriented professional to join our organization in the capacity of Senior Validation Specialist. This position requires strong technical knowledge, effective communication skills, and a deep understanding of regulatory requirements.

Key Responsibilities:


• Develop comprehensive documentation for validation processes.


• Translate complex technical concepts into clear language for diverse stakeholders.


• 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, and change control processes.

Qualifications:


• Bachelor's degree in a relevant field (Master's preferred).


• Minimum 5+ years of experience as a technical specialist in the pharmaceutical or life sciences domain.


• Strong understanding of validation principles, GAMP guidelines, and regulatory frameworks.


• Excellent technical writing, editing, and stakeholder engagement skills.


• Knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms.



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