Validation Engineer:

Years of experience :5-10 Years 

Notice period : 30 days 

•           Responsible for ensuring the accuracy, completeness, validation and compliance of deliverables by plan/lead/review/train/guide/support of the validation packages of IT applications in a regulated industry
•           Actively participate in the Validation Life Cycle of regulated IT projects by
•           Planning validation deliverables
•           Working on validation documentation
•           Authoring Validation Plan & Validation summary report
•           Review of User requirement specifications, functional requirement specifications and Design requirements specifications
•           Creation of traceability matrix
•           Review of validation protocol development (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)) and Test Summary Reports.
•           Executed scripts reviews and deviation management
•           Working with cross-functional project teams to support validation activities
•           Provide guidance/feedback to IT project teams in Validation compliance as per the applicable regulatory
•           Proficient in GAMP , 21 CFR Part 11, EUAnex11 and GDP.
•           Facilitates IQ working with Business Analyst, Development Team and Compliance Engineer
•           Facilitates OQ working with testing team, Business Analyst and Compliance Engineer
•           Facilitate PQ working with Business user community and Q&R. – Major Keyword