What are the responsibilities and job description for the Software Quality Engineer position at KYYBA?
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 provide audit support
• Working with a range of applications/tools including, Track Wise, JIRA, Confluence, and other integration tools.
ALM
Education min. / Experience min.- Bachelor’s with 8 years of exp. or Master’s with 5 years of exp. (Required: Resumes must include the candidate’s Bachelor’s or Master’s graduation year.)
Top 5 skills/requirements –
• 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
Interview preferences : • Video
