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CURRICULAM VITTAE

M E H U LKUMAR J. P A T E L

D-204/ SUDARSHAN HOMES APPARTMENT, NEAR BHAGVAT TEMPLE, SOLA, AHMEDABAD - 380060, GUJARAT, INDIA

Phone: +91-989*******~ E-mail: ad193n@r.postjobfree.com PROFILE SUMMARY:

Dynamic business process analyst and quality compliance-oriented CSV-Quality Assurance Professional with 16+ years of experience in Manufacturing Execution System (MES), ERP (SAP), JIRA, SDLC, qTest, STLC, Agile, eQMS, CSV, CSA, Quality Assurance, Documents management, Risk management, Project Management Planning (PMP), Vendor/Supplier Management, Audit managementfor LifeScience/ Pharmaceutical industry for regulatory compliance with optimizing existing processes and to be more productive.

ORGANISATIONAL EXPERIENCE

Presently associated with Rockwell Automation-Feb 2020, Lead-Functional Consultant Rockwell Automation is a tech giant Hardware and IT company, the group’s design and developed software and services business for pharmaceuticals and life sciences across the globe. Headquartered in the United States, the group has global operations in across world.

• Possesses a clear understanding of Life Science/ Pharmaceutical industry, digital technology trends with the distinction of instituting quality compliance practices to achieve business excellence of BusinessSoftware, GxP software, PLC and SCADA at the lowest overall cost and financial parameters.

• In-depth knowledge and exposure of MES, ERP, LIMS, GAMP5, GxP software, CSV, 21 CFR Part 11, EU Annex 11, Data integrity, Risk assessment, QMS, cGMP, cGLP and cGCP.

• Expert in MES (PharmaSuite, Rockwell Automation) ERP (SAP) channel integration with PI server, LIMS and Machine interface consulting with client and it’s business requirements components to design software functionalities to achieve desire output of business need as per ISA88 batch control and machine integration as per ISA95 standard of layer architecture.

• Requirement gathering from client for software compliance as per business need and actively involved in handling of software product development (SDLC) and evaluation of manual/ automatic software testing life cycle (STLC) for compliance functionality testing.

• Identify change orders and justify changes to Project Management to resolve issues and establish priorities between projects and handling & follow up project management planning (PMP) to deliver project milestone on defined timeline.

• Prepare, review, and approve of GxP and business application of computer system validation (CSV) entire life cycle documents Page 2 of 5

deliverables (URS, VP, RA, FS, DS, CS, SAT, UAT, RTM, IQ, OQ, PQ, VSR)according to GAMP5 guideline.

• Vendor/ Supplier Assessment and self-inspection according to ISO standard guideline & SOP.

• Assist clients with resolving application problems and installing software upgrades as well as patches management for GxP systems.

• Excellent planner with proven abilities in accelerating growth and generating customer loyalty levels while managing process.

• Verticals with strong background in implementing process improvements and quality initiatives for desired performance levels.

• Hands-on experience in project management activities including scoping, estimation, finalization of technical / functional specification, resource administration and quality management.

• Works alongside top management for evolving strategic vision, driving change, infusing new ideas and taking enterprise system performance and qualitative to the next level.

• Excellent communication and interpersonal skills with proven abilities in resolving complex technical and commercial issues collaborating with cross functional departments and support teams and decision maker. Dec, 2019 – Feb,2020, Sarjen Systems Lead-CSV GxP software for Life science/ Pharmaceuticals Sarjen System is an IT company, the group’s design and developed software and services for pharmaceuticals and life sciences across the globe. Headquartered in the city of Ahmedabad in India, the group has global operations in three continents spread across USA, Europe & Asia.

• Possesses a clear understanding of Life Science/ Pharmaceutical industry, digital technology trends with the distinction of instituting quality compliance practices to achieve business excellence of BusinessSoftware, GxP software at the lowest overall cost and financial parameters.

• In-depth knowledge and exposure of GAMP5, GxP software, CSV, 21 CFR Part 11, EU Annex 11, Data integrity, Risk assessment, QMS, cGMP, cGLP and cGCP.

• Evaluation of initial GxP risk assessment of software and identify its category as per GAMP5.

• Prepare, review, and approve of GxP and business application of computer system validation (CSV) entire life cycle documents deliverables (URS, VP, RA, FS, DS, CS, SAT, UAT, RTM, IQ, OQ, PQ, VSR)according to GAMP5 guideline.

• Support to client of global regulatory USFDA, MHRA, TGA, EMA-EUGMP, WHO-GMP, and ISO: 9001:2015, etc.

• Expertise with quality aspect point of view in QMS likes, Change Controls, CAPAs, Risk Assessment and Deviations, in eQMS application. Functional expertise in Solid oral, Sterile operation of Pharmaceutical Formulation Plant.

• Vendor/ Supplier Assessment and self-inspection according to ISO standard guideline & SOP.

• Assist clients with resolving application problems and installing software upgrades as well as patches management for GxP Page 3 of 5

systems.

• Verticals with strong background in implementing process improvements and quality initiatives for desired performance levels.

• Hands-on experience in project management activities including scoping, estimation, finalization of technical / functional specification, resource administration and quality management.

• Works alongside top management for evolving strategic vision, driving change, infusing new ideas and taking enterprise system performance and qualitative to the next level.

• Excellent communication and interpersonal skills with proven abilities in resolving complex technical and commercial issues collaborating with cross functional departments and support teams and decision maker. Jul, 2012 – Nov, 2019 -Zydus Cadila Healthcare Ltd - Deputy Manager Zydus Cadila is global pharmaceutical company, the group’s operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India, the group has global operations in four continents spread across USA, Europe, Brazil, South Africa and 25 other emerging markets.

• Expert in SAP&MES two-way transaction channel integration with PI server developed and document reviewed.

• Prepare and review document of User management with access privileges management and Audit trail management of pharmaceutical GxP softwares.

• To review documents of Historian and OPC server integration to MES.

• Contribute to the continuous improvement and optimization of the MES (PharmaSuite, Rockwell) and eQMS (Track wise, Sparta) systems.

• Support (Maintenance & troubleshooting) of MES related projects, strong cooperation with IT and MES user team.

• Expert to review of automation/function validation life cycle documentations as per GAMP5.

• Expert in spearheading the entire QMS activities and operations of Change Control, Deviation Report, investigation, Corrective and Preventive Actions, in Track wise software.

• End to end PLC/SCADA up gradation project handling in pharmaceuticals/ Life Science to ensure compliance as per data integrity, 21 CFR part 11 EU Annex 11 and GAMP5 guidelines.

• Preparation of SOPs, gap analysis, compliances of SOPs through “Documentum” software.

• Reviewing Quality of master documents like (BMRs, BPRs and Protocols) and ensuring the Compliances of cGMP/GDP.

• To handling training of through “ZyTims” Software.

• Independently managing the country regulatory approval AUDIT of USFDA (United States Food and Drug Administration) for the GxP software.

Feb, 2011 - Jul, 2012 - Intas Pharmaceuticals Ltd- Officer (QA/IPQA) Page 4 of 5

Intas Pharmaceuticals limited and Intas Biopharmaceuticals Ltd. is an Indian company headquartered in Ahmedabad, India. The Biologics BU is inMoraiya, Ahmedabad and is one of the leading bio similar product manufacturers in Asia and Europe. Feb, 2009 - Feb, 2011 - Zydus Hospira Oncology Pvt. Ltd. - Officer (QA) Zydus Hospira, the Company’s 50:50 JV with Hospira Inc., USA set up in 2009-10 for commercial manufacturing of oncological injectable. These products would be marketed by both Hospira and Zydus Cadila in the respective territories assigned to them. Now Zydus Hospira, is migrate to Zydus Pfizer the Company’s 50:50 JV with Pfizer Inc., USA Feb, 2007 - Feb, 2009- Lincoln Pharmaceutical Ltd – Officer (QA) Lincoln Pharmaceutical Ltd. is a Public Limited Company. It has its own EU complies manufacturing facilities, covering all the major dosage forms, like Tablets, Capsules, Injectable, Syrups, Ointments, etc. is located near Ahmedabad. Reporting:

• Sr. Project Manager and Sr. Solution Architect

CORE COMPETENCIES

• Expert to handle SDLC and STLC for GxP projects management milestone deliver as per quality product.

• Prepare, review and approve of GxP and business software validation life cycle documents (CSV) as per GAMP5.

• Internal & external (Quality) audits of System, Vendor/ supplier qualification, assessment and documents.

• Software knowledge of Rockwell-PharmaSuite (MES), Sparta-Track wise (eQMS), Sarjen-QEdge (eQMS), Sarjen-ProcessXE

(MES), Caliber-LIMS (QC), SAP-ERP, Documentum (DMS), Minitab (CPV & PQR) and MS Office.

• Expertise integration with MES: ERP, Scale, Scanner, Machine, QMS, LIMS

• Exposure of qualifying MES, eQMS & DMS software. ACADEMIC CREDENTIALS

DR.H.L.T. COLLEGE OF PHARMACY, RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, Bachelor of Pharmacy (B. Pharmacy) – 66.3% -2003-2007 SHRI.B.R. PATEL NUTAN FELLOWSHIP HIGH SCHOOL,

Gujarat Higher Secondary Education Board, Ahmedabad, Gujarat Higher Secondary Certificate (H.S.C) - 51.8% - 2002 RANIP SHRI SARVAJANIK HIGH SCHOOL,

Gujarat Secondary Education Board, Ahmedabad, Gujarat Page 5 of 5

Secondary School Certificate (S.S.C) - 78.5% - 2000 PERSONAL DETAILS

■ DATE OF BIRTH: DECEMBER 20, 1984, ■GENDER: MALE ■MARITAL STATUS: MARRIED ■NATIONALITY: INDIAN

■LANGUAGES KNOWN: ENGLISH, HINDI & GUJARATI

Thanks fully,

MehulKumar J. Patel

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