1 - 9 years
1 - 9 Lacs
Posted:1 day ago|
Platform:
On-site
Full Time
Key Deliverables: Develop and execute validation plans and protocols for GxP-regulated systems Ensure system documentation complies with 21 CFR Part 11, Annex 11, and CSA guidance Support change control, incident handling, and periodic review for validated systems Collaborate with cross-functional teams to maintain continuous validation throughout the lifecycle Role Responsibilities: Perform risk-based assessments and define validation scope and strategy Coordinate user and functional requirement gathering and document reviews Maintain validation artifacts using platforms like Veeva, KNEAT, or ALM Provide post-deployment support and ensure ongoing system compliance
Amgen Technology Private Limited
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