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S. K.
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Canton, MI
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Summary: Total 8 plus years of experience as a QM/ PP-PI functional consultant in diverse industry verticals including Pharmaceutical, Chemical and Automotive Industries. Excellent understanding of business process modeling, process improvement, Mapping of process As Is and To Be workflows as well as Gap Analysis. Successfully completed Four Full life cycle implementation, Two Global Rollouts, one Production Support and Two Upgrade projects. Extensive experience with Blue Printing, Gap Analysis, Configurations, and preparing Functional Specifications Document (FSD), Testing as well as Deployment and Production Support. Extensively worked on capturing data requirements, Data analysis, Data validation & mapping data as well as Data Conversion and load data using LSMW and BDC. Excellent understanding of RICEF objects dependencies and documentation of the RICEF objects. Strong in cross module experience of QM Integration with in MM, PP-PI, SD and PM modules. Have very good understanding of cGMP (Current Good Manufacturing Practice), 21 CFR part 11 (as per FDA requirements) and ISO: 9002 regulations. Experienced in developing training manuals and providing one to one and group training to users. Extensively involved planning and executing Unit testing, Integration Testing, End to end testing, Role based testing and user accepting testing (UAT) Detail oriented with multitasking and strong interpersonal skills with ability to resolve issues. SAP QM Skills: Excellent understanding of QM integration with core SAP modules and the central functions that impact QM. Configuration of Inspection types, Defining Control Key, Block Delivery, DMR, SPC/SQC, Inspection Points, Defect Recording, Batch Classification and Interfacing with STAR LIMS. Configuration of Quality planning and Quality Inspection as well as configuration of Quality Certification and Quality Notifications and CAPA. Configuration of settings related to Stability Study (Basic data, Samples, Testing Schedule, Quality Notification and Stability Test). Excellent understanding of Quality in Procurement, Quality in Production and Quality in Sales and Distribution with knowledge of Quality Control Practices. PP-PI Skills: Very Strong in serial number management and automatic Batch determination. Implementation of Batch Search Strategies for Process Order. Worked on Material calculation which is most important requirement of this kind of industry. Defining and configuring BOM, Production Version, MRP controllers, Resources, Master Recipe Selection and Back flushing. Extensively worked on Material Calculation, Process Orders, PI sheets, Electronic batch records, Process messages. SAP PP Skills: Excellent understanding of integration with core SAP modules (CO, MM, QM, IM, WM and SD) and the central functions that impact Production Planning. Extensively designed and configured the Master data, BOM, Routings, Long-Term Planning, detailed scheduling, SOP, Demand Management, Capacity Planning and Back flushing. Extensively worked on MTO and MTS strategies and Customized own strategy groups. Configuration of settings for Order Types, order type dependent parameters, MRP plant parameters and Scheduling Parameters. OWENS CORNING, Toledo, OH (WHQ) Aug 2008- Nov-2008 Role: PP/QM Senior Consultant Project: - Implementation through Rollout approach: SAP ECC 6.0 -Upgrade from SAP R/3 4.6C to SAP ECC 6.0 Owens Corning is a leading global producer of residential and commercial building materials, glass fiber reinforcements and engineered materials for composite systems. I was working on two projects simultaneously. Responsibilities: Gathered Requirements, analyzed and mapped them for QM module. Updated Blue Print Documents for Quality Management Module according to Standard Operating Model Requirement. Explained Functional Specification to developers and got approvals for workaround from users as required. Updated Function Specifications for custom Tables, Customized Reports and Customized Screens for shop floor controls. Maintained Dependency Matrix for custom tables, custom transactions and RICEF Objects Interdependencies. Used Solman to Create Operating Structures for Blue Print Documents, Function Specs and Configuration Documents and maintained them. Identified OSS notes provided for Release 620 to resolve issues of syntax errors during Production Order Creation related to IS-Discrete Industries and Mill Products (SAP ECC-DIMP) Worked with VERP, MCRO, MCHE and MCHF Material types. Defined planning strategy 83, Routing selection, BOM explosions, creating Purchase requisition for materials and subcontracting services. Configuration of Plant Factory Calendar, Number Ranges for Routing ,Number Ranges for Processing Orders, Control Keys, Order Type and Order Type Dependent Parameters, Batch Management including Batch search Strategies for Production Planning Defined Work Center Parameters, Standard Value Key, Activity types, Control Key, pooled capacity and Formulas for Work Centers. Developed Configuration Documents for QM Basics, QM Planning and QM Inspection. Configuration of Catalogue, Inspection Type, defect classes, Tolerance Keys, Print Control, Forms, automatic usage decision, Status Profile for Certificate Profile, Certificate Type, Form, Data Origin, notification types, Screen Templates, Catalogs & Catalog Profiles for Notification Type, confirmation profile for Quality Management. Developed and Maintained Test data for PP and QM. Involved in uploading Master data MIC, Inspection Plan, Routing, BOM and Production Version using LSMW. Developed Test Case for Unit Testing of PP and QM configuration as well as all RICEF objects identified. Identified user exit EXIT_SAPLV01Z_012 and EXIT_SAPL01V_014 to get the value of the customer material number from the sales order line to Batch characteristics using batch creation program LGHRGF02, enhancement spot save_batch_01 pass space to the parameter no_cfc_call used to trigger the required user exits. Developed Integration Test Case for PP and QM Module. The Coca Cola Co, Atlanta, GA Mar 2008- July 2008 Role: QM/ PP-PI Functional Consultant Project: Implementation; SAP ECC 5.0 A global leader in the beverage industry, the Coca-Cola Company offers hundreds of brands, including soft drinks, fruit juices and sports drinks. QM Responsibilities: Configured customized inspection type for procurement, in process inspection and intra company stock transport orders (STO). Defined and maintained Q Info Records and Quality score for vendor block and vendor evaluation Configured DMR during procurement and in process inspection. Activated vendor invoice blocking using QM functionality. Customized notification for Vendor complaint, Customer complaint, Customer Returns and Audit Inspection. Used Solution Manager for mapping the processes. Extensively involved in preparing test plan for unit testing, integration testing, end to end testing as well as role based testing in development and quality server. PP-PI Responsibilities: Defined Control Recipe and PI sheets for process management. Defined new Process instructions as per client requirements. Defined and Configured Batch Management and Batch search strategy using shelf life expiration date check in process orders. Configuring new order type and its dependent parameters for PP-PI process orders. Set up Goods issue, receipt postings and time ticket confirmation of phases using process messages to the corresponding message destinations and Status updates in process order during control recipe monitoring. Prepared test plan and executed them for Role based testing and Integration testing. Power user training and end user training covering entire cycle of PP-PI including ECM (Engineering change management) for Bills of material and Master Recipe, Result recording and usage decision in Quality Management (QM). DUPONT, WILMINGTON, DE July 2007 - Mar 2008 Role: QM/ PP-PI Functional Consultant Project: Global Rollout; SAP R/3 4.6C DuPont is one of the biggest chemical companies and has many plants across the world. In the Present scope of implementation, South Asia, Mexico and USA. Some of US plants have SAP 4.6C. Responsibilities: Reviewed global template for business requirements for different plants. Identified gaps of different plants w.r.t global template and defined deltas. Used functionalities of active ingredient in Batch Management. Used functionality of Material Calculation in PP-PI Master Recipe. Process messages, PI sheets and Electronic batch records were created for data update. Control recipes were mapped for capturing and controlling the data. Demand Management was used to for independent requirements. Make to stock strategy was used for major products. Make to order also mapped for some products Defined QM-IDI interface for LIMS system. Prepared functional specification and field mapping specification for Data transfer through IDOC. Defined DMR for Incoming and In process Inspection, Control indicators for control chart type to retrieve data and made sure that control is compatible with inspection characteristics and sampling procedure assigned. Developed Test Scenario and Test scripts for Unit Testing, Integration Testing and Regression testing. Master data collection and validation was completed for First roll out. Used LSMW to migrate MIC, Inspection Plan and Catalogues. BOM, Resources, Master Recipe using BDC, Production Version, Usage Decision Codes, Code groups, Classes and Certificate of Profiles loaded manually. Developed training documents, conducted training workshops for end users and super users and assisted users in UAT. Also involved in go live and currently involved in production support activities. ALBEMARLE CORPORATION, RICHMOND, VA FEB 2007 - JUNE 2007 Role: PP/QM Functional Consultant Project: Implementation and Production Support; SAP ECC 6.0 Albemarle Corporation is a leading producer of specialty chemicals for consumer electronics; pharmaceuticals; agricultural, automotive and industrial products; and construction and packaging materials. Responsibilities: Assisted in Defining 'AS IS' & 'TO BE' processes in Blue Printing, also involved in GAP analysis. Customized Production Order Types and worked extensively with availability check. Configured MRP based on user requirements by defining MRP groups and MRP Controllers. Configured work center formula, designed standard value keys and scheduling formula Involved with Inspections for Goods receipt with Purchase Order, GR for Production Order, Goods Receipt for STO, In process inspections, Recurring inspections based on Shelf Life, Goods issue inspections, Inspections during delivery with or without sales orders. Extensively involved in Unit Testing, Integration Testing and Regression Testing. Prepared Test Plan, Test Scenario and Test Data. Loaded test data using eCATT Scripts. Extensively involved in Data Cleansing and validation in spreadsheets and used LSMW to upload data like BOM, Work Centre, MIC and BDC to upload Routing and Inspection plans. Other data like UD code, selected sets and Batches were loaded manually. Prepared User Training Manuals and conducted User training sessions for QM module using Infopak. Earned recognition for Identifying and resolving issues in time as well as for maintaining defect management matrix during Production support. SOLVAY PHARMACEUTICALS INC., MARIETTA, GA APR 2006 - JAN2007 Role: QM/ PP-PI Functional Consultant Project: Technical Upgrade; SAP R/3 4.6C - SAP ECC 5.0 Solvay Pharmaceuticals is dedicated to optimal patient health management. Solvay Pharmaceuticals produces drugs related to neurological, gastroenterology and Cardio-Metabolic disorders. Responsibilities: Studied the business processes and gathered information from process owners and end users to develop testing plans. Tested business process, all transactions, custom transaction, master data and custom tables in development and quality system. Maintained Defect Management Matrix to track defects. Check configuration settings in R/3 4.6C and ECC 5.0 to make sure everything is moved to new system. Ensured CFR part 11 compliance with use of Digital Signature and Digital Records. Identified screen layout features in new version ECC 5.0 and analyzed its relevance to R/3 4.6C system. Prepared Test plan, Test Scenario and Test scripts for UAT. Assisted users in UAT. Extensively tested role based authorization with positive and negative scenario. NABI BIOPHARMACEUTICALS, BOCA RATON, FL JUNE 2005- MAR 2006 Role: QM/ PP-PI Functional Consultant Project: Implementation and Production Support; SAP R/3 4.6C Nabi Biopharmaceuticals is focused on products that address medical needs such as nicotine addiction and gram-positive bacterial infections. Responsibilities: Extensively gathered requirements from business users. Defined RICEF objects dependencies and documented RICEF objects. Configured Production scheduling profile, Order Types, order type dependent parameters, MRP plant parameters and availability check. Implemented planning strategy Make to stock and Make to Order scenario. Configured quality planning, DMR and Quality Inspection as well as configured certification, notifications and Test Equipment Management. Ensured quality inspection for extended warehouse (decentralized) using Quality Inspection Engine. Ensured compliance with 21 CFR part 11 (as per FDA requirements) using Digital Record Maintenance and Digital Signature. Provided training to Business Owners for implementation and post implementation maintenance support. Involved in issue resolution related to QM-IDI interface for LIMS. HWASHIN AMERICA CORP., GREENVILLE, AL OCT 2004 - MAY 2005 Role: PP Functional Consultant Project: Global Rollout; SAP R/3 4.5B Hwashin America Corp. is a manufacturer of automobile chassis and body parts, and has been a leading player in the Korean automotive industry. With its headquarters in South Korea, the company also has plants in the U.S., China, and India. Responsibilities: Prepared AS-IS and TO-BE documents based on global template and business requirement, also assisted in identifying Deltas. Configuration of order type dependent parameters for standard production order and Rework order. Configuration of scheduling parameters for standard production order and Rework order types. Configured Batch Management, Batch Classification and Batch Search Strategies for Production Control. Extensively used LSMW to upload data like MIC, code groups, BOM, Work Center and BDC to upload inspection plan, Routing and Production version. Conducted User Training Workshops and assisted Users in UAT. Attended and assisted in conducting Variant Configuration training workshops. Identified issues and resolved them during post go live support. THE ANIL STARCH PRODUCTS LTD, INDIA APR 2003 - AUG 2004 Role: PP-PI/QM Functional Consultant Project: Functional Upgrade; SAP R/3 4.6C Company produces a diverse range of starch and related down stream products like Dextrose Monohydrate, Liquid Glucose (Corn Syrup), Sorbitol and many more... Responsibilities: Understand AS-IS process, Gather requirement from process owner. Prepared TO BE process documents and identified deltas for change in business process for executing Process Order and PI-PCS interfacing for PLC. Configured settings as per revised business process. Defined functional specifications for Custom transaction and custom reports. Involved in Unit Testing, Role based Testing and end to end testing. Updated Training documentation w.r.t. new business process. Conducted User trainings and assisted Users in UAT and got signoff from Users. Involved in Go live and production support. LUPIN Ltd., ANKLESHWAR, INDIA JAN 2002 - FEB 2003 QM/PP-PI Functional Consultant Project: Implementation; SAP R/3 4.6C Lupin has 10 API/intermediates and finished products facilities across 5 different bases in India. Major therapeutic focus areas: anti TB, cepholosporins (both orals and injectables), ace inhibitors, statins and prils. Responsibilities: Gathered requirements from users and prepared AS- IS and Blue Print documents. Configured customized inspection type for transfer goods from one SLOC to another within a plant as well as for the Incoming inspections, In-process Inspections, Inspections during STO, Inspections during delivery with sales orders as well as Returned Delivery Inspection. Maintained BOM, routings, control keys, production orders and special procurement keys to take care of the planning and production issues. Configured background jobs for MRP run, Batch Search Strategies and Backflushing. Extensively involved in testing i.e. Unit Testing, Integration Testing and Regression testing. Developed User Training Manuals and Conducted User Training Sessions. Assisted Users in UAT, extensively involved during go live and post go live support. BHARTIA-CUTLER-HAMMER (BCH), DELHI, INDIA JAN 2001 - NOV 2001 ROLE: QM/PP Functional Consultant Project: Production Support; SAP R/3 4.6C Bhartia Cutler-Hammer (BCH), a business unit of Bhartia Industries Ltd., is a leading manufacturer of Low Voltage Switchgear & Control gear. The Company was set up as a joint venture between Cutler-Hammer, USA, and Indian partners. Responsibilities: Assisted users to define custom inspection type and assign it to material as a part of new business requirement. Identified issues, prioritized them and resolved them in time. Extensively used OSS notes to resolve issues. Provided training to new users for QM and PP module. Took initiative for documenting common issues encountered and conduct User Training Workshop every month. ALEMBIC LIMITED, BARODA, INDIA MAY 2000 - NOV 2000 Business Analyst Alembic (ISO: 9002) is manufactures of pharmaceuticals, antibiotics, macrolides and veterinary products for livestock and poultry; bulk drugs. Responsibilities: Effective requirements gathering and the elicitation of the requirements. Convert the gathered requirements into clear, concise business requirement documents. Actively contributed in the JAD sessions to baseline the business requirement documentation. Developed the data flow diagrams and effectively defined the business process models. Assisted QA team for developing test plan and test scenarios for extensive system testing. Prepared test plans, test conditions and test case for user acceptance testing and solely conducted user acceptance testing (UAT). I had also prepared user training manuals and conducted user training sessions. Prepared test data and performed data testing using the SQL comprehensively. Also used MS excel for data mapping and data analysis. Developed requirements traceability matrices and used it for tracking requirement status through initiation till deployment. Conducted user training sessions, coordinated post audit meetings and effectively documented the lessons learned. Education: BS in Microbiology and BS in Industrial Microbiology
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