Maragoni Ramu
adcf3n@r.postjobfree.com
Visa Status: H1B
Location : Valencia, CA.
Mygo Consulting
https://www.linkedin.com/in/ramu-maragoni-78bb1356/
Summary
** ***** ** ********** including Business, Consulting & SAP encompassing a wide range of skill sets, roles and industry verticals.
Industry specialization in Medical Device,Pharmaceutical & Bio-Tech Industry Experience in various Business and Consulting roles.
Experience:
5 implementations and 2 rollouts for Class-III Medical Device, Pharmaceutical, Chemical & Food industries.
5 support projects for Medical Device, Pharmaceutical, Chemical and other process industries.
Lead Solution Architect for Class-III Medical Device Company in implementing SAP – Production Planning, Production Planning- Process Industries, Quality Management, SAP – MES (CAMSTAR) integration, SAP-PLM (Oracle) Integration.
UDI (Unique Device Identification) implementation experience with medical device industries.
Involved in analysis, design, development, customizations and implementation of SAP Quality Management (QM), Production Planning (PP), Materials Management (MM) & Warehouse Management (WM) applications.
Involved in SAP validation projects for regulated industries.
Implemented X-step based PI sheets.
Implemented best practices for Medical Device and Pharmaceutical Industries.
Proficient in analyzing and translating business requirements to technical requirements and architecture.
Knowledge of cGMP processes.
Exposure to FDA regulations, 21 CFR part 820 & 21 CFR part 11 guidelines.
End to end Implementation experience SAP QM, PP-PI/PP, SAP-MES, 3rd party PLM-SAP integration.
Experienced in working with RICEFW objects.
Requirements gathering, leading blue print sessions and Gap analysis.
International Exposure in working across the Globe (USA, UK, Europe and India)
Managing Testing & Validation.
Conducting training sessions to GKU’s (Global Key Users) and GPO’s (Global Process owners)
Coordinating with Business, Functional & Validation Testing Teams.
Exposure SAP HANA s/4 and working knowledge of SAP Fiori
Education
Bachelor’s in Pharmaceutical Science – (1997 -2001), JNT University, India
PG Diploma in Bio-Informatics – (2001 – 2002), IGIB-INFORMATICS, New Delhi, India
Technical Skills
SAP - PP-PI / PP
SAP - QM
SAP - MM
SAP - WM
SAP - PM
SAP - Batch Management
SAP - Serial Management
SAP - PI sheets with X-steps
SAP - IDCOS, BAPI
SAP - LSMW
SAP Mill - DIMP functionality
SAP – Medical Device UDI (Unique Device Identification)
Oracle PLM - SAP integration for Master Data Transfer
End to End SAP – 3rd Party MES Integration (CAMSTAR)
(PP/PP-PI Master Data, BOM, Routing, WProduction Planning, MRP, Forecast, Reorder Point Planning, Dynamic Safety Stock, Shop Floor Execution, Product Costing, Material Management, Inventory Management, QM Master Data, Quality Inspections, Quality Planning, Supplier Quality, Quality Info Records, Quality certificates, Quality Notifications, Stability Studies, Batch Management, Original Batch Management, Serial Management, SLED, Batch Derivation, Batch Determination, Picking, Final acceptance, Stop Ship, Non – Conformance, Deviation Management. Material Master, Vendor Master, Purchase info Records, Picking Strategies, HU Management, Put away Strategies, Bulk Storage, Storage Sections and Bins
Integration Areas
PP-QM integration
PP-WM integration
QM-MM Integration
PM-QM integration
QM-WM integration
QM-SD integration
PP-SD integration
PLM-SAP Integration (Oracle PLM)
SAP-MES Integration (CAMSTAR)
Tools
ARIS Builder
HPQC
IBM Manage Now
Solution Manager
Share Point
E-Room
JIRA
LSMW
INNOWERA
MS-EXCEL, WORD, POWER POINT
Work Experience
Illumina, Inc. Aug. 2019 – Feb. 2020.
Illumina is a medical device company which develops, manufactures, and markets integrated systems for the analysis of genetic variation and biological function. The company provides a line of products and services that serves the sequencing, genotyping and gene expression, and proteomics markets.
Responsible for extension of the solution in SAP – PP and SAP CAMSTAR integration for the existing and new manufacturing plants.
Responsible for SAP PM QM Integration
Work with business team in translating business requirements into Functional Requirements Document and to Detailed Design Documents
Lead analysis sessions, gather requirements and write specification and functional design documents for enhancements and customization; Analyze product impact
Develop implementation and test plans as per the validation guidelines (21 CFR part 820)
Sonova International. Aug. 2015 – Aug. 2019.
Sonova is the leading manufacturer of innovative hearing care solutions. Through core business brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova and offers product portfolios in the industry – from hearing aids to cochlear implants to wireless communication solutions.
SAP Implementation – Advanced Bionics – Phase1
SAP Implementation – – Advanced Bionics – Phase2
SAP Rollout – Phonak.
Role: Senior Business Systems Consultant : SAP PP/QM/MM
Responsible for implementation SAP –PP, PP-PI, SAP – QM, PLM – SAP Integration & SAP – MES Integration.
Work with business team in translating business requirements into Functional Requirements Document and to Detailed Design Documents.
Responsible for designing interfaces between Oracle PLM SAP (Material Master & BOM transfer)
Responsible for designing interfaces between SAP MES (CAMSTAR) (Production Order Launch interface, Pick interface for inventory transfer, POU Consumption Interface, Operation Confirmation interface, Consumption Posting/Scrap interface, Order confirmation/Final Acceptance interface).
Responsible for designing the error handling in-case of interface failure.
Lead analysis sessions, gather requirements and write specification and functional design documents for enhancements and customization; Analyze product impact
Present and defend product designs and architecture to business
Coordinate and communicate tasks with developers.
Ensure that development is performed as per requirements
Work with Business and Validation to create test scripts and scenarios for enhancements and customizations to the core product
Communicate activities/progress to project managers and GPO’s (Global Process Owners)
Develop implementation and test plans as per the validation guidelines (21 CFR part 820), build software acceptance criteria, coordinate and work with clients to oversee the acceptance and dissemination process
Conducting training sessions to GKU’s (Global Key Users) and GPO’s (Global Process owners)
Deloitte Consulting - July 2011 – June 2015.
SAP Implémentation – Project Hercules -Univar Chemicals
SAP Deployment – Heinz Foods
SAP Implementation – Project OASIS – American Colloids
SAP Implementation – Project GO - Cytec Chemicals
Role: SAP – QM/PP-PI/PP/BM Consultant
Responsible for implementation SAP –PP & SAP – QM modules for Univar Chemicals.
Work with core team in translating business requirements into Functional Requirements Document and to Detailed Design Documents
Lead analysis sessions, gather requirements and write specification and functional design documents for enhancements and customization; Analyze product impact
Present and defend product designs and architecture to clients
Coordinate and communicate tasks with developers
Ensure that development is performed as per requirements
Work with QA to create test scripts and scenarios for enhancements and customizations to the core product
Communicate activities/progress to project managers, business development, business analysts and clients
Develop implementation and test plans, build software acceptance criteria, coordinate and work with clients to oversee the acceptance and dissemination process
Environment: SAP ECC 6.0
IBM India Pvt. Ltd. (Dec. 2008 – July 2011)
SAP Implementation / support - STADA Pharmaceuticals, Germany
SAP support - Ball Packaging Europe, Germany
SAP support - Agrana Foods, Europe
Role: SAP PP/PI- QM Consultant
Responsible for delivering solution to our customer in the Process Industry.
Deliver new and complex high-quality solutions to clients in response to varying business requirements
Responsible for managing scope, planning, tracking, change control, aspects of the project.
Responsible for effective communication between the project team and the customer. Provide day to day direction to the project team and regular project status to the customer.
Translate customer requirements into formal requirements and design documents, establish specific solutions, and leading the efforts including testing that culminate in client acceptance of the results.
Utilize in-depth knowledge of functional and Technical experience in SAP with industry and business skills to deliver solutions to customer.
Establish Quality Procedure for the team and continuously monitor and audit to ensure team meets quality goals.
Spectral soft Technologies Pvt. Ltd. (Jul. 2007 – Nov. 2008)
Spectra Soft Technologies Pvt. Ltd is a SAP implementation company in Pharmaceutical & Chemical Industries having prestigious pharmaceutical clients like Orchid Chemical, Shanta Biotech. My role is as follows:
SAP Implementation -Orchid Chemicals & Pharmaceuticals.
SAP Implementation – Shreya Life Sciences
Responsible for Implementation of SAP – QM modules for Shreya Life Sciences.
Involved in SAP ECC 6.0 Implementation in Shreya Life Sciences, Mumbai.
Work with core team in translating business requirements into Functional Requirements Document and to Detailed Design Documents
Lead analysis sessions, gather requirements and write specification and functional design documents for enhancements and customization; Analyze product impact
Present and defend product designs and architecture to clients
Coordinate and communicate tasks with developers
Ensure that development is performed as per requirements
Work with QA to create test scripts and scenarios for enhancements and customizations to the core product
Communicate activities/progress to project managers, business development, business analysts and clients
Develop implementation and test plans, build software acceptance criteria, coordinate and work with clients to oversee the acceptance and dissemination process
Environment: SAP ECC 6.0,
Biological Evans Ltd. (Corporate Validation Group) – July 2006 – July 2007
Role: Executive – QA
Responsibilities:
Responsible for validation of pharmaceutical formulations facility and design
Responsible for validation (process & equipment’s) as per US FDA guidelines
Medule Pharma - Mar 2004 – July 2006
Role: Officer – Production
Responsibilities:
Responsible for production of solid dosage forms and parentals
Preparation of daily prod reports and shift schedules
Responsible for audits (US FDA)
Updating Batch Processing Record
Aurobindo Pharma Ltd. – June 2002 – Mar 2004
Role: Executive – Production
Responsibilities:
Responsible for production of solid dosage forms
Production Planning
Manpower Planning
Preparation of Shift Schedules
Preparation of daily prod reports and shift schedules
Responsible for audits (US FDA)
Trainings or Certification
SAP PP-PI & QM by IBM.
SAP SCM 7.0 by SAP
SAP PM
SAP-DP