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Senior Software Engineer
Hyderabad, Telangana, India
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Description
• Execute Computer System Validation (CSV) activities for GxP applications, laboratory systems, manufacturing systems, and enterprise platforms.
• Develop and review validation documentation including: Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications, Design Specifications, Test Scripts (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
• Ensure compliance with regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q7/Q10) and company SOPs.
• Collaborate with cross-functional teams (QA, IT, Manufacturing, R&D, and Business Units) to ensure timely validation delivery.
• Perform risk-based assessments to prioritize validation testing.
• Provide audit support for regulatory inspections and internal quality audits.
• Train project teams on CSV processes, documentation standards, and compliance requirements.
• Participate in data integrity assessments and remediation projects.
• Support continuous improvement of CSV procedures, templates, and best practices.Required Skills Good to Have Skills
Education
Any Gradute
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