Alok Joshi

Background

About Alok Joshi

A dynamic professional with 19+ years of experience across SAP LANDSCAPE Validation, Spreadsheet/Excel Validation, IT Validation, 21 CFR Part 11, Operations Maintenance, Quality Assurance, Client Relationship Management, SDLC and Data Analysis. Expertise in Validation(IT Systems)/GxP regulations/21 CFR Part 11 Knowledge of Computer Systems Validation, System Development Life Cycle, and GAMP5 guidelines Manage the validation activities including preparation & review of documents like Validation Plan, User Requirements Specification, Functional Specification, Risk Assessment, Design Specifications, Test Plan & Script, Traceability Matrix, Validation Summary Report, User Training Manual & Others. To ensure compliance for computer systems, validation requirements, Policies & Procedures (bases on GAMP5 guideline) to meet the regulatory requirements and support for various regulatory & statutory audits. Ensuring & conducting the training of the users on the new and existing software solutions, IT SOPs. To arrange / conduct the IT team training on new IT SOPs. Well versed with Quality Assurance processes, Test strategies and Test Methodologies Prioritize multiple tasks effectively; taking into account factors such as project scope, deadlines and urgency of need to ensure business results are met. Lead testing process improvement activities, to identify and resolve quality related issues across organizational boundaries. Specialties: SAP ECC / S/4 HANA Validation Spreadsheet/Excel Validation System validation Requirement Gathering Quality Assurance Regression Testing