Mahendra Mewada
CSV Lead
SHAJAPUR
Summary
To succeed in a stimulating and challenging environment, building the success of the company where I can continuously learn in the pursuit of achieving functional excellence, consequently getting maximum job satisfaction and optimum career growth Determined Validation Engineer with over 7 years developing and executing validation master plans. Background authoring and approving validation protocols in addition to coordinating with other personnel to drive success. Stellar problem-solving, decision-making and communication skills. Conscientious Validation Engineer with 7 years overseeing development on safe, effective products. Specializes in GAMP 5, 21 CFR part11, Annexure 11, AlCOA and ALCO +to maximizing safety and efficacy of deliverables to encourage customer loyalty and drive revenue growth.
Overview
5
5
years of professional experience
Work History
Validation Lead
TATA CONSULTANCY SERVIES
2 2021
- Working on PLM project in ARAS Application
- Preparing of supporting SDLC documents for software/equipment
- Experience in developing and enhancing the standard operating procedure as part of the SOP program
- AS per SDLC prepare Develop software test plan (TP), user requirement specification (URS), validation plan (VP)functional specification (FS), functional risk assessment (FRA), design specification (DS), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), traceability matrix (RTM), validation summary report (VSR) and system released certificate
- Handling deployment process SIT, UAT and Prod according to Project timeline
- Good understanding of regulatory information management & associates business processes
- Support end to end data preparation & readiness, data assessment and data enrichment and data completeness
- Prepare project plan and discussion with user to project and support teams for functional expertise
- Provide CSV end to end training, business drive management and integration and configuration of software
- Check new feasibility of the new changes, requirement and provide the client with clear timeline
- Provide techno functional doc, source code review and solution support for all the new business implementations, while building the entire system configuration
- Code review as per the development accordance to design specification
- Discussion to client and provide project status
- Remotely manage server and Build deployment SIT/UAT, Prod deployment procedure
- Handling deviation and discrepancy and manage inventory or all deliverables documents.
Sr. Validation Engineer
TATA CONSULTANCY SERVICE
12.2018 - 02.2020
- Working on project of SAP ECC6.0 (SD, PM,MM,PP)
- AS per SDLC prepare Develop software test plan (TP), user requirement specification (URS), validation plan (VP)functional specification (FS), functional risk assessment (FRA), design specification (DS), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), traceability matrix (RTM), validation summary report (VSR) and system released certificate
- Developed Final report for IQ, OQ, &PQ protocols
- Finalized CSV requirement As Per 21 CFR part 11
- Implemented corrective and preventive actions
- Performed gap analysis between FDA and regulations
- Documented to testing results execution qualification protocol as per user requirements
- Creating user accounts and performing access control
- Must meet productivity and accuracy standards.
PLC Validation Engineer
Sun Pharmaceuticals Industries Ltd.
03.2017 - 11.2018
- Working on project of PLC /HMI and SCADA, ERP
- Experienced in laboratory method validation, process validation, water system and worked with many automation processes like coating machine, CVC line, compression machine, VTD, dino mill
- Blister packing machine
- Preparing of supporting life cycle document equipment, software and instrumental validation including Qualification of software, equipment instrument as per CSV process
- Qualification of software, equipment, instrument and preparation of document according to the category as per GAMP 5 guideline
- Handling backup & maintenance of SCADA and HMI
- Vendor/client co-ordination
- Performing diagnostic tests and debugging procedures to optimize computer systems
- Documenting processes, as well as backing up and archiving data.
Service Engineer
Integral solutions (Indore)
08.2015 - 03.2017
- Working on project of PLC /HMI and SCADA
- Preparing of supporting life cycle document equipment, software and instrumental validation including
- Qualification of software, equipment instrument as per CSV process
- Qualification of software, equipment, instrument and preparation of document according to the category as per GAMP 5 guideline
- Handling backup & maintenance of SCADA and HMI
- Vendor/client co-ordination
- Prepare inventory of every equipment.
Education
B.E (ELECTRICAL & ELECTRONICS ENGINEERING) -
Mahakal Institution of technology
Skills
21 CFR Part 11
Annexure 11
Alcoa and Alcoa
Documentation and reporting
Microsoft word, excel, PowerPoint
Requirement analysis
Application Installation
Desktop Support
Application Support
Accuracy and Precision
Effective Communication
Process Analysis
Equipment Calibration
Process Validation
Data Integrity
Regulatory guidelines
Testing protocols
Quality Management Systems
FDA regulations
Validation Protocols
Maintenance of engineering systems
Engineering systems testing
Validation Testing
Audit processes
Accomplishments
- Visited M.P.E.B.(Madhya Pradesh electric board ) shujalpur, (M.P)
- Participated the event 8051 Engineered conducted by GGI, Bhopal.
- Hobbies: Movies, Listing music, cricket, video game
Personal Information
- Father's Name: Mr. Chandar Singh Mewada
- Mother's Name: Mrs. Lata Mewada
- Date of Birth: 07/03/1992
- Marital Status: Single
Roles And Responsibilities
- Working as Team leader and of computer system validation and Software development.
- Develop software (PLC, SCADA, DAS and HMI/IPC) to follow Pharma guidelines and Regulatory (21 CFR part 11, GxP& GAMP guidelines).
- Expertise in using document, SharePoint, SAP, Track wise, LIMS and ERP system.
- Good working knowledge of company product, process, procedures and personnel.
- Experienced working with in quality assurance, preferably with in food/ medicine device / pharmaceuticals industry / lifscience organization's.
- Awareness / understanding of the medical directive Gamp, GDP, ISO, Who, CSA.
- Sustain and support the complaints management system as needed.
- Excellent understand of SDLC. GLP, manual testing.
- Vendor and client co-ordination.
- Remotly managing IT support and desktop support calls.
- Fault and alarm management: Alaram monitoring and resolution.
- Responsible for handling the objective evidences, managing the associated deviation and systems issue and discrepancy.
- Developed CSV training for new users and update SOPs as per new policies.
- Involved in management, maintenance log, Reteival and archival of documents and records electronically using sharepoint.
- Troubleshooting business related application and co-ordinate with the concerned team to resolve the problem. Maintenance of Desktop, Laptop.
- EBR (Electronics Batch Records )
- Installing, configuring and troubleshooting of MS Windows OS, MS Other Software and internal office applications.
- Performing LAN/WAN troubleshooting and Client-server connectivity Support.
- Ladder Logic Programming.
- PLC Programming Schneider Electric, &AB (Allen Bradley).
- Software developer (SCADA, DAS and HMI), Sematic EBR.
- Computer platform: -Windows Family.
- Tools: RS Logix 5000, RS Logix 500, Factory Talk View Studio, RS View 232, Ethernet, Unity Pro, Vijeo Citect
Currentlocation
Indore
Languages
Hindi, English
Disclaimer
I hereby declare that the particulars furnished above are complete and correct to the best of my knowledge and belief.
Timeline
Sr. Validation Engineer
TATA CONSULTANCY SERVICE
12.2018 - 02.2020
PLC Validation Engineer
Sun Pharmaceuticals Industries Ltd.
03.2017 - 11.2018
Service Engineer
Integral solutions (Indore)
08.2015 - 03.2017
Validation Lead
TATA CONSULTANCY SERVIES
2 2021
B.E (ELECTRICAL & ELECTRONICS ENGINEERING) -
Mahakal Institution of technology