5+ years of experience in Computer System Validation, Customer Requirements Analysis, Business Analyst and Validation Projects of Pharmaceutical application. • Build Deployments (SAT, VAL, PRD) with SQL server (2014 and Higher) and IIS (7.0 and higher) • Successfully delivered 3 Projects LIVE and Assist more than 5 Projects to the team. • Develop expertise in product knowledge, technical knowledge, Industry and process knowledge in relevant product areas. • Testing – Experience in Unit testing, Integration testing and user acceptance testing along with IQ, OQ and PQ. • Ensuring Quality deliverables which meets internal and external stakeholder requirements. • Analysing Client Requirement, preparing user stories/Propose Solution, Specifications. • Preparation Technical Documents Functional Specifications, Protocols with Qualification documents • Experienced in project documentation – Handled project life cycle documentation from template creation to document archival. • Hands-on experience in writing protocol and executing Operational Qualification (OQ) and Performance Qualification (PQ) scripts for Pharmaceutical applications.• Experience in validation of automation projects including iLab, CaliberLIMS & Pharmaceutical Products. • Strong working knowledge of FDA 21 CFR Part11, EU Annex 11 processes for Security and Regulatory Compliance for Pharmaceutical Applications. • Excellent communication and team building skills with ability to balance and work with a variety of internal and external stakeholders. • Knowledge on the Preparation of standard solution which are used in Labs. • Good hands on experience of Microsoft Word, Excel, PowerPoint. • Thorough understanding on Clinical Trial process (Phase I-IV) and Clinical Data Management process. • Thorough knowledge of data validation processes (like Discrepancy review, DCF life cycle etc.) including Quality control process. • Knowledge ICH-GCP guidelines, Regulatory Authority, CDISC guidelines. and Medical Terminology. • Understanding on the Pharmacopoeias.