PROFESSIONAL SUMMARY:

• 8+ yrs. of experience in Validation and Quality Assurance.
• Experience in writing Spreadsheet Validation.
• Replaced existing manual paper validation process with Digital Spreadsheet Validation process that reduced manual process and was cost efficient.
• Involved in planning the test data.
• Experience in writing, reviewing, revising and implementing Validation Deliverables such as User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), and Validation protocols (IQ/OQ/PQ), Validation Summary Report and Test Summary Report.
• Knowledge of GLP, GCP, cGMP, GMP, 21CFR part 11, guidelines especially in the areas of computer or related systems use.
• Experience in Good Document Practices (GDP).

TECHNICAL SKILLS:

Validation Deliverables: Validation Plan, Test Plan, RTM, URS, FRS, OQ, PQ Protocols, Sop s/Work instructions, System problem reports and System Summary/Compliance Report.

Computer System Validation: 21 CFR Part 11, 820, cGxP (cGMP, cGAMP, cGDP, cGLP), IQ, OQ, PQ, RTM, SOP, Work Instruction, SDLC, ICH guidelines

Operating Systems/Server Applications: Windows2000/2003/XP/Vista/7/NT

Tools: MS Office (Word, Excel, PowerPoint), MS VISIO, Share Point, SAP GUI 740, WMS (Manhattan) 2015, WCS, Wave Link, Documentum, Remedy, JIRA and HP Quality center.

PROFESSIONAL EXPERIENCE:

Confidential, Boston, MA

Validation Engineer/Quality Assurance

Responsibilities:

• Conducted connectivity and performance testing on interfacing applications: Manhattan (WMS - Warehouse Management Systems), WCS (Warehouse control Systems), Wave Link (RF Scanners) and SAP.
• As part of this project we performed validations such as Infrastructure application functionality, business functionality, process review.
• Performed internal design review of testing requirements, setup test environment, preparedtest plans, executed test cases, reported and tracked defects.
• Involved in all phases of upgrade testing from Phase 1, cycle 1- 2 and Phase 2, cycle 1 -3 which included executing and validating test scripts for UAT (User Acceptance testing).
• Raised P1 Issues and re-executed the testing before we went to go-live.
• Coordinated the user acceptance testing and regression testing activities inSAP GUI 740 and WMS (Manhattan) for the new order creation process, outbound product handling, FEDEX and UPS shipments, customer and site returns, product movement to DSM (Daily stock management-Exceptions).
• Worked as a SME (Subject matter expert) on new processes.
• Worked cross functionally with Quality, Production, Manufacturing, Supply Chain, Customer service, Business Process lead, Quality release, Regulatory affairs, R & D for implementation of new process and system changes for Quincy 2.0 project within the site and for data migration for doing testing or validating the process.
• Migrated the materials from North to South (Old to new Location) area, and performed the related migration testing using the task groups created to check the functioning of new application and the movement of materials.
• Tested the inventory sync - Verifying inventory is in sync between SAP and Manhattan as per infrastructure functionality.
• Executed the inbound DC process - STO/Purchase Order. Verifying process is accurate to receive stock transfer and goods from vendor and Good receipt in Quincy DC through Manhattan.
• Executed the outbound process - Waving/Short pick/Cancel/Order Combine/Split/Single/Pallet. Typically involves creating customer order to ship the goods.
• Executed the outbound DC process - Packing list/Shipping Labels/Invoice. Validating customer information is correct.
• Executed PLC operated Intelligrated Automated Conveyor system, which is used for handling shipper box for customer.
• Performed informal and formal UAT testing for kitting, Rework and Postponement products.
• Experience on Manhattan WMOS and supported the Production area after the go-live of the project, by looking in to the issues raised by the users and performed regression testing in solving them.
• Created process flow diagrams for all the processes.
• Worked as a coordinator in providing the s to entire site or to the users and involved in preparing test data.
• Assisted/Trained the entire site for the creation of Sales Order, Distribution orders, ASNs (Advance Shipment Notice), OLPNs (Outbound license plate number), iLPNs (Inbound license plate number), Wave number, and how to use Task groups in the distribution center from picking, Packing and shipping the product and moving them to exceptions.
• Experience in writing Test Scripts for all the regression testing’s executed (Emcision, Symatis and etc).
• Depending upon the priority level logged the tickets throughout the complete life cycle Using JIRA(P3/P4) and REMEDY and tracked and managed the issues on priority level.
• Used RF scanners for purposes and performed performance testing on RF devices or Scanners which included movements with RF device and integration of RF devices within SAP and WMS for connectivity testing.
• Responsible for writing validation documents and also execution of IVOT (Installation Verification and Operational testing) protocols (IQ/OQ/PQ) for conveyors, Pack and seal Equipment, Print and Apply equipment, Pack size machine. Created and printed labels on WMS (Warehouse Management System) Software.
• Tested and validated the laser printers, scanners, refrigerators (for life cell drugs/products) formally and informally in the UAT testing.
• Involved in validation of computer-related systems and process equipment.
• Analyzed the User and Functional requirements to point out gaps as part of GAP analysis.
• Executed Test Cases, and reported defects for Quincy 2.0 project at Confidential Corporation.
• The database is connected to SAP having Manhattan application as UI.
• Trained to eCAPA procedures, pFMEA, PDM, PLM and TrackWise Global Complaint System 2.
• Used to update the documents in PLM (Windchill), Created change request, and routed for approvers.
• Supported the Standard Operating Procedures (SOPs) and Work Instructions (WIs) creation, change and update for the new processes to align with AMS Integration Systems.
• Involved in validation of computer-related systems and process equipment.
• Analyzed the User and Functional requirements to point out gaps as part of GAP analysis.
• Participated in discussions with business to collect high level requirements, and created BRD from the business discussion.
• Used to update the documents in PLM (Windchill), Created change request, and routed for approvers.
• Created IUBR for DSM Smart form, Build Plan and HR Spreadsheet Validation.
• Created Spreadsheet validation for Build plan, it is used as a tool to help production supervisor or designee to manage build plan for the week.
• Created DSM Smart form spreadsheet validation for Daily Stock Management Form is used daily by Operators to document the conditions of the product being pulled from Unrestricted Stock and moved to the DSM Room for disposition. The current version is a word doc and is being converted to excel smart form.
• Prepared spreadsheet validations and IUBR for customer service for their Internal Audit.
• Created a Paper PDC Spreadsheet validation (HR spreadsheet validation). The Spreadsheet is used to manage employee’s performance.
• Used to update the documents in PDM/PLM (Product data management/ Product lifecycle management), Created change request, and routed for approvers.
• RF Scanners
• Handled root-cause investigations, gap analysis for reviewing complaints on Scanner Inventory Management Tool (RF Scanners-Radio Frequency).
• Responsible for writing test cases for scanner inventory management tool (RF Scanners).
• Created IUBR for scanner inventory management tool.
• Created Validation Document (MVP) for Scanner Inventory Management Tool.
• Used to update the documents in PDM/PLM (Product data management), Created change request, and routed for approvers.
• Created Gap analysis template and Work Instructions for Rework Products.
• Involved in Quincy Rework Process, provided updates on Rework Activities on weekly basis in Quincy.
• Used to update the documents in PDM/PLM (Product data management/Product lifecycle management), Created change request, and routed for approvers.
• Participated in lean (lean essentials) and involved in the meetings.

Confidential, CT

QA Analyst

Responsibilities:

• Take part in testing and implementation of new projects and Enhancement Requests.
• Co-ordinated with other teams such as database, user interface and testing teams to accomplish the task.
• Supported post implementation Issues
• Documented all activities involved in the system implementation process.
• Created Test Cases in Quality Center, executed Test Cases, and reported defects.
• Developed documentation for all aspects of computer systems testing and analysis including risk assessment.

Confidential, NJ

Programmer/Analyst

Responsibilities:

• Involved in User acceptance testing by documenting and writing the test cases on applications that are internally used.
• Responsible for identifying and documenting business rules and creating detailed Use Cases
• Ability to work on multiple projects simultaneously and meet the dead lines as and when required.
• Performed validation on derived datasets and following the standard operating procedures during the validation process.
• Used SAS procedures like Proc freq, Proc means, Proc Sort, etc. to test, compare, understand and prepare the test data.

Confidential

Data Analyst

Responsibilities:

• Duties included validation of computer-related systems, manufacturing facilities, and process equipment.
• Involved in User acceptance testing by documenting and writing the test cases on applications that are internally used.
• Responsible for identifying and documenting business rules and creating detailed Use Cases
• Ability to work on multiple projects simultaneously and meet the dead lines as and when required.
• Performed validation on derived datasets and following the standard operating procedures during the validation process
• Preparation and/or review of requirement specifications and qualification protocols and analysis of 21 CFR Part11 compliance.
• Played a key role in the EDMS (Electronic Document Management System - Documentum).
• Participated in the validation of Documentum 5.2.5.
• Indexed Documents using appropriate keywords or Tags and stored Electronic Documents in the EDMS (Documentum).
• On-site protocol execution; data analysis; and preparation, review and approval of final reports. Also performed audit of warehousing processes.
• Qualification of a Computer System Application including IQ/OQ protocol generation, execution and final report generation.
• Involved in Requirements Traceability Matrix (RTM) to track requirements during the Testing Phase.
• Facilitated collection of User Requirements from system users and preparation of business requirement documents that provided appropriate scope of work for technical team to develop prototype and overall system.
• Conducted GAP Analysis and Remediation of Lab instruments for Part 11 compliance.
• Involved in and documented 21 CFR Part 11 Checklist and Assessment to ensure that the system is in compliance with 21 CFR Part 11 requirements according to FDA Regulations.
• Reviewed and prepared software validation protocols like IQ, OQ, PQ and User Acceptance Tests.
• Worked extensively with the QA team for designing Test Plan, Test Cases for the User Acceptance Testing.
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification and System Design Specification document.
• Involved in creating and updating of Standard Operating Procedures (SOPs).

Confidential

Analyst

Responsibilities:

• Created test suites and verified SAS applications to meet needs of Clinical project.
• Participated in data mapping. Analyzed business requirements with multiple and various users’ community, carried out various analyses and wrote application specifications.
• Tested SAS program to create Clinical Summary Reports.
• Performed diverse analyses and tested SAS programs using Proc Tabulate, Proc Report
• Seminar presentation on COLON TARGETTING (Drug Delivery) conducted by Osmania University.
• Participated in the AICTE sponsored National level seminar conducted by the university and presentation was on BULK DRUG INDUSTRY-OPPORTUNITES AND CHALLENGES IN INDIA.
• Participated at Symposium on Agriculture Biotechnology-Food and Nutrition Security, organized by NIN Scientists Association (NINSA).
• Participated in the industrial conducted by NATCO PHARMA and CHEMINOVA PHARMACEUTICALS.
• Statspin expresses 2-product specifications (centrifuge) project, team leader, FMEA analysis was submitted.
• Familiar with 21 CFR, ICH guidelines, GMP and GLP requirements.
• Hands on experience with 510(K) submissions and trained on IND, NDA, BLA (Biologic license Application), PMA applications and De-novo classification request to the FDA.
• Documented a section of an Investigational New Drug (IND) application on a fictitious drug.
• Gained an overview on Quality System Management, reviewing validation protocols, clinical investigations.
• Experience in using FDA form 3500 and form 483.
• Knowledge in adverse event reporting and Medical Device Reporting.
• Good documenting, negotiating and problem-solving skills.
• Provided a case study on “Bio-Patenting—A study on Patenting Life forms”.
• Project on “Life Cycle Management” in practical aspects of regulatory compliance.
• Informed Consent Exercise for REMICADE Clinical Study.
• Case Study Project on “Clinical Trial in Uganda”.
• Warning letter responses, Batch Manufacturing Records and SOPs following Good Documentation Practices.
• FDA (Pre-IND) Meeting Request Exercise Project.
• Case Brief Projects and Exercises on Food Drug Administration and Medical Device Law.
• Knowledge in human anatomy and physiology from my Bachelor’s program.