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Sap Medical Device

Location:
Valencia, CA, 91354
Salary:
150000
Posted:
March 25, 2020

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Resume:

Maragoni Ramu

661-***-****

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



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