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Validation Engineer

2 months ago

new delhi, India Antal International Full time
Job Description 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 specification  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 regulator 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 Keywords

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