Adil Wahab Email and Phone Number

Project: The project includes preparation, review and approval of validation master plans, protocol and reports, interpretation of data and protocols based on the appropriate standard operating procedures (SOP). The company used Labware LIMS and it was used for managing the samples, laboratory users, instruments, standards and other laboratory functions such as invoicing, plate management, and workflow automation. Responsibilities:● Worked closely with users, and the enterprise application group to understand and document user requirements, and functional design specifications. ● Followed the company's SLC during creation of the documents related to testing.● Gathered information from owners of Spreadsheets belonging to various departments like QC, R&D, and Microbiology for their corresponding GxP relevance.● Created Requirement Traceability Matrices (RTM) from the Functional Requirements and other specifications documents.● Generated change controls forms for updates to system functionality to validated applications.● Authored Test Summary Reports (TSR) at the end of each testing cycle and Validation Summary Reports (VSR) at the end of the validation process.● Developed Validation Master Plan (VMP) that outlined the testing activities.● Prepared all required documents in validation lifecycle in agreement with FDA regulation including Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for Labware LIMS.● Developed and executed validation guidelines for testing cGxP sensitive transactions.● Worked both independently and cooperatively with other team members on multiple projects with competing deadlines.● Designed test plans and test cases for testing the functionalities of the applications. ● Performed positive, negative, unit, integrated and system testing to existing applications

Project: Objective of my first project was to assure that the (QMS) TrackWise system is in compliance with 21 CFR guidelines. The second project involved validating Word using a tool, A4L. The tool convert word document into XML PM to meet American and Canada Health Authority compliance. In my third project, the main responsibility was to validate the Text Verification Tool used by Drug Regulatory Affairs team (DRA) Clinical Supply Operation (CSO) team for comparing label, artwork of product.Responsibilities (Project – I): ● Reviewed and approved the Validation Deliverables (Validation Plan to Validation Summary Report) of involved systems software and TrackWise.● Involved in document management and project management through SharePoint.● Designed validation plans, oversaw execution of the plans, and reported validation activities on validation summary reports.● Created and maintained validation documentation for assigned products/projects.● Monitored any deviation and addressed such to management team for Change Control.● Maintained compliance with 21 CFR Part 11 for assigned systems.● Prepared and executed Validation Protocol documents like IQ, OQ, PQ, and User Acceptance Test.● Interacted with the users and TrackWise developer team to qualify configured modules in TrackWise web team access and TrackWise administrator.● Creating tickets for LIMS regarding equipment or procedure ● Update LIMS programs for new users to work efficiently using oracle software● Determined the need for revalidation based upon changes to systems.● Contributed to the overall development and maintenance of policies and procedures as related to compliance activities.● Executed OQ scripts for the Chromatography Data Acquisition System (CDAS), Empower 1 and Empower 2.