Roles & Responsibilities:

• 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 Enginee
•  Facilitate PQ working with Business user community and Q&R.