JD key points which we can expect from Validation Engineer/ Validation Engineer for Philips.
Exp : 5 to 7 Yrs
- Experience Computer System Validation, Infrastructure Qualification,GAMP5,FDA Regulatory guidelines
- Work experience in Projects following agile methodology.
- Experience Authoring, reviewing and Approval of Compliance documents, Eg: Validation Plan, URS (User Req. Specification),FRS (Functional Req. specification) and DS(Design Specification) Testing protocols (IQ, OQ, PQ), Summary reports (IQSR, OQSR, PQSR etc.) Test summary reports, Defect Management.
- Knowledge on 21 CFR Part 11
- Experience in handling validation activities
- Experience in participating in 1:1 Onshore calls, client engagements
- Experience in participating in Product Categorization document, Test plan, Test scenarios, Test Cases (authoring, execution and review), Automation ,Automation Framework design ,and Test metrics, providing functional support,
- Good to have experience in resolving client issues/defects on live environments.
- Good and Effective Communication (oral and written ) skill and a good team player
- Good to have experience in ValGenesis tool.
- Good to have experience in Team(8 to 10 people) handling skills
Want more jobs like this?
Get jobs in Bangalore, India delivered to your inbox every week.
