Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications; Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc.
Collaborate with the cross-functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met.
Review of CAPAs, Change Controls and Defects for GxP applications.
Working with Global teams and providing audit support.
Working with a range of applications/tools including ALM, TrackWise, JIRA, Confluence, and other integration tools.
Requirements:
Bachelors with 8+ years of exp. or Master's with 5+ years of exp prefered.
Prior experience in regulated industry - GxP systems.
Good knowledge of FDA regulations; 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485 and ISO 27001.
Quality Management Tools and Test Management Tools - TrackWise/ComplainceWire/Veeva, ALM, JIRA etc.
Knowledge about Data Integrity and prior audit support experience (Internal/External).
Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-shelf (COTS) and Custom applications.
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