Mitul Singh

Phone: 630-***-****(Mobile)

E-Mail: adeqgf@r.postjobfree.com

Profile Summary:

Engineering graduate experienced in Quality, Manufacture, Engineering, Validation, software testing domain, End-User Administration (IT), and Inventory Analyst, I also hold extensive knowledge of MS Office Suite with advanced Excel. Experienced in handling successfully several projects as a Project Lead. I have good experience in providing training to a team on the ERP system and managing team. I have experience in validation (CSV-E, IQ, OQ, PQ), NCR, nonconformance, quality hold, CAPA, and all the activities that need in the quality and manufacturing area. I am a dedicated team player able to give value in a challenging work environment, and the ability to deal with problems involving a variety of concrete variables in standardized. Experience within a highly regulated environment (e.g. FDA regulated), 21 CFR 820, ISO 13485, ISO 14971, ISO 9001,GxP, GAMP 5, and other related life science standards experience. Demonstrates skill in applying various risk management and risk mitigation tools and practices. Supervise and directs the efforts of the Quality Control Department.

Education: University Name: R. P. Sharma Institute of technology

Bachelor’s Degree in Engineering

Certification:

1.PMEC (Project Management Essentials Certified)

2.Six Sigma Yellow Belt

3.Scrum fundamental

4.Negotiation Associate

5.C programming Language

Technical Skills:

Experience in a machining environment

Experience in accomplishing as a quality engineer and validation lead on multiple projects.

Experience in accomplishing several Remediation Projects.

Knowledge to Collaborate with Manufacturing and Technical Operations to complete process risk assessment (FMEA). Identify and drive implementation of continuous improvement activities to control risks at acceptable levels and prevent quality issues.

Experience in nonconformance of product, quality hold, NCR, HHED (Health Hazard Evaluation Determination), CAPA in the manufacturing and quality area.

Mentor a team of Quality Assurance professionals by assisting in objective settings, provide constructive feedback and motivate them to become more efficient.

Strong problem solving and people management skills and demonstrated ability in exercising judgment and sound decision making.

Expert in Investigating the use of using an out of tolerance (OOT) measuring test equipment or gage for impact on equipment, process, and product.

Basic Knowledge of assorted quality system like gage R&R and GD&T.

Good experience in Audit of quality and engineering documents.

Good Knowledge of cGMP’s, GAMP, and data integrity requirements.

knowledge of IQ, OQ, PQ, CSV-E (Computer System Validation Equipment) and understanding of the FDA predicates. Experience on Manufacturing Transfer and hands on experience in a machining environment.

Experience in developing validation plan, Validation Assessment, Compliance Analysis, URS, Risk Assessment, Compliance Pan, Test Plan, Hardware Qualification, Testing, Test Report, Compliance Report, Installation Qualification Protocol, Installation qualification Report etc.) and paperwork included in getting validation of new equipment and existing equipment.

Expertise in developing validation Protocols for Installation Qualification.

Experience and good understanding of document management systems.

Proven experience in independently leading large, high complexity, high-priority strategic projects.

Tool / Technology: COMPUTER SYSTEMS VALIDATION (CSV),share point, SAP, CMS, ETQ, WOW, SERDAAK, JDE, ENOVIA, DOC.VIEW, PLOT VIEW, DCS, HMS, SALESFORCE, CRM, LIVELINK, MICROSOFT WORD, EXCEL, SQL, DCT TOOL, WORKFLOW, AS400, FASTPORTALO, C PROGRAMMING LANGUAGE, BWS, BMC REMEDY, EZACCESS, XA, JOB BOSS, MASTER CONTRO, SAP, CDR, ADAPTIVE, GAGE INSITE, BLUE PRINT,GD&T,MINITAB,CAD and C3.

Professional Experience:

DePuy Synthes Johnson & Johnson- Sr. Quality Engineer/ Lead (December 2018–Still working)

In this role, I looked after multiple strategic projects, coordinated Quality Assurance and validation activities including CSV-E on multiple strategic projects. Coordinated third- party vendor Taking care of all Project activities such as organizing, planning, execution, and production support.

I accomplished the audit Remediation project before the due date by my innovative ideas and reduced the cost and time of the project. Played a vital role in a closer writeup audit project in the ETQ system. I highlighted preventive measures for opportunities to reduce the cost of quality.

Team leading a cross-functional group in improving processes across the business. I audited all Creation modification form project and organized all the documents in the ERP system. Planned and directed improvement activities for the current process, equipment, material, and product to meet customer needs.

Plan, Track, and create reports and matrix of all my current projects. Review monthly overdue gages and Creation modification form. I have the responsibility to generate quarterly QPR (quality Progress Report) and matrix of the calibration department.

I am currently working on validation with CSV-E as an SME and Author (IQ,OQ,PQ,Validation Assessment, Compliance Analysis, URS, Risk Assessment, Compliance Pan, Test Plan, Hardware Qualification, Testing, Test Report, Compliance Report, Installation Qualification Protocol, Installation qualification Report, etc.). As an author responsible to complete all the validation paperwork of new equipment and existing equipment.

Apart from my project and daily work I contribute all the necessary help which requires in my department.

Zimmer Biomet - Quality Engineer (August 2016 –December 2018)

In this role, I successfully completed CAPA, Remediation, nonconformance, HHED (Health Hazard Evaluation Determination) project. I completed successfully Calibration of Inspection, Measuring, and Test Equipment investigation. I reviewed the nonconformance. Successfully Investigated out of tolerance gages, reviewed, and closed the NC.

In this role completed IQ, OQ, PQ, and, CSV-E on new and existing equipment. Experience on Manufacturing Transfer and hands on experience in a machining environment.

I Worked on NC (nonconformance) - Investigate NC, Confirm the Non-Conformance details, and move the Product Disposition to plan. NC investigation and Action Creation and Implementation for planned and non-planned. Investigate the use of using an out of tolerance measuring test equipment or gage for impact on equipment, process, and product. Issued and Investigated non-conformances using a systematic approach to problem-solving, conducted risk analyses, and recommended and oversaw the implementation of corrective and preventative actions with the goal of assuring quality and minimizing risk to the consumer.

In this role, I also, completed successfully quality hold of, NCR, HHED, Validation, CAPA, assess the impact and scope OOT cases have on production and validation. Coached peers on ETQ and HHED project.

Instru-med Inc. - Quality administrator (June 2016-August 2016)

In this role I Maintained corporate controlled Document (CCD). I worked on Routing complaints, Corrective and Preventive Action (CAPAs), Non-conforming Material Record (NCMR), maintaining calibration/certificates, Maintaining weekly metrics for production and quality departments, extracted from enterprise resource planning (ERP) and Quality Management System (QMS) software records, including production orders by department; complaints, gage R&R, CAPAs and NCMRs opened/closed; and quality metrics of orders shipped.

I also worked on Gage R&R, control plans (due to Print changes and / or changes in outsource supplier(s), and CNC machine validation: IQ, OQ, PQ.

Avalign Cutting Instruments - Quality Inspector/ Engineering Tech (November 2015 – May 2016)

I worked as an engineering and quality role in this organization. I updated work instructions and routed for approval in the QMS system. I Worked on spreadsheets to manage the quality department changes as FDA Registration Spreadsheet, Risk Management – PFMEA, Measure Protocol, etc. I also, worked on spreadsheets to manage the quality department changes as FDA Registration. I Validated and made changes in the Company's new logo, Procedures.

I also, Audited the router folder, updated prints, and maintained engineering files electronically in the ERP system. In, this role I used my skills in merging the two company’s quality documents.

Instru-med Inc. - Quality Administrator (July 2015-October 2015)

In this role, I worked for the Organization of Device History Records (DHRs). I Inspected several orders, routed to receiving or final component inspection operations, per inspection check sheet requirements (100% or at the acceptable quality level (AQL)), locating inspected part features on the customer print.

I worked on Routing complaints, Corrective and Preventive Action (CAPAs), Non-conforming Material Record (NCMR), maintaining calibration/certificates, Maintaining weekly metrics for production and quality departments, extracted from enterprise resource planning (ERP) and Quality Management System (QMS) software records, including: production orders by the department; complaints, gage R&R, CAPAs and NCMRs opened/closed, and quality metrics of orders shipped.

Zimmer Biomet - Inventory Analyst (March 2015-June 2015)

In this role, I provided statistical report to distribution management personnel and exhibit a high degree of detail and analysis when formulating decisions and recommendations. I Managed Inventory restrictions and par levels as required to monitor inventory deployment. I was updating daily weekly and monthly reports, scorecard, Distributor B/O report, Expired Spreadsheets update and run a macro, Power ranking, MBR scorecard, Field Inventory Scorecard, Maintain/Cancel orders, DI reduction, Distributor DI charges, Processing Exchange form.

I managed to run, Macro and update the daily report and Execute product obsolescence, expired, or transfer plans to ensure smooth transitions are met.

I Performed intermediate to advanced statistical analysis, add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals. I Effectively presented all the information to management. Perform related duties and project assignments as required.

Zimmer Biomet - End User Administrator (January 2015-March 2015)

In this role, I provided level one and two customer and technical support, including how-to questions, to customers through inbound phone and email requests. Independently identify, troubleshoot, documents, and replicates simple to complex customer problems and then resolves or escalate complex problems according to escalation procedures and knowledge management process requirements. Retained ownership of the customer relationship on all cases throughout the resolution process which required follow-up with customers and involvement with other IT groups. Reports enhancement requests and defects received from customers on hardware, application, or documentation and communicate to the right IT staff.

I created user ID and provided access to path globally.

3GSOFT Solutions– Quality Software Test Engineer (April 2006-March 2007)

Perform different types of testing (functional, acceptance, browser compatibility, load, stress, performance and volume), Silk Test, Win Runner, Load Runner, Test Director Windows 7, Windows 8 Microsoft desktop and server operating systems, Microsoft Windows 95/2000/XP/Vista/7, Windows Server 2000/2003/2008, and Microsoft Office Pro Suite. I Executed different testing and generate results e.g. functional, installation, acceptance, browser compatibility, load, stress, performance, and volume etc.

In this role, I Wrote and executed test cases. Also, Developed execution plans and URS. I successfully did the Verification and validation of software. I reviewed SDLC documents, Risk assessments and any other information required as part of the software Validation process.

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