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Shreya Sharma
Research Associate
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Validation Engineer
The vacancy has expired
- LocationIndia
-
IndustryIT-Software / Software Services / Testing
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