Aditya Beri

acch21@r.postjobfree.com

(1-817-***-****)

CAREER CONSPECTUS

Strong experience in Process Validation (IQ, OQ, PQ) & Software Validation.

Proficient in Regulatory compliance ( ISO 13485, ISO 9001, 21 CFR 820).

Certified Six Sigma Black Belt from the American Society for Quality.

Certified Internal Auditor – RABQSA ISO 9001:2008

Certified Six Sigma Green Belt for Process Improvement from Institute of Industrial Engineers.

Proficient in Production & Inventory Management (APICS CPIM) supplier management, MRP.

PROFESSIONAL EXPERIENCE

Kimberly Clark Corporation

Quality Validation Engineer, Conway AR

November 2012 Present

Executed 70+ Process Validations & 25+ Software Validations in Class I and Class II Medical Device manufacturing

environment.

Writing & executing protocols; analyzing results; and preparing reports IQ, OQ, PQ for Process and Cleaning &

Sanitization Validations.

Writing, executing, reviewing URS (User Requirement Specifications); Test Protocols and Reports for Computer

System Validations (CSV).

Updating and maintaining Validation Master Plan.

Determining sampling plans for Manufacturing and Validation samples based on AQL and RQL.

Developing procedures, work instructions and templates for Validations.

Continuous validation procedure improvements via the change control system

Auditing departments/functions per ISO 13485, 21 CFR 820 and QMS.

Supporting corrective and preventive actions through the CAPA system, tracking CAPA status and managing

responses.

Welspun Tubular Corporation

Quality Engineer, Little Rock AR

January 2012 November 2012

Applying principles of quality, quality management and statistics to analyze technical information and prepare

technical documents. Responsible for documentation and proposal writing under API 5L, ISO 9001 and CSA

standards.

Conducting QMS audits in different department across the facility. This includes audit planning, execution,

documentation, reporting with CAPA, and review of third party audits.

Participating in external audits, with the registrar (API) or with clients.

Retrieving and interpreting technical data from SAP and internal / external lab reports / test certificates.

Summarizing data and generating statistical analysis utilizing Minitab software.

Providing internal training on the QMS and any additional quality material.

Participating in pre production meetings with clients and any other meetings.

Quality Supervisor, Little Rock AR January 2011 December

2011

Establish and maintain quality management system in coating plant.

To ensure that all plan production, inspection and testing are performed as per approved QAP, process charts and

work instructions.

Ensure classification of non confirming product into suitable categories such as rework, reject.

Ensure to use calibrated instruments at required stations at all the times.

To be part of continual improvement and any modifications for the improving the product quality.

Analyzing quality related issues on daily basis and ensuring adequate corrective and preventive action are taken.

Lead Quality Inspector, Little Rock AR April 2010 January 2011

Responsible for performing line inspections for 30”, 36” and 42” diameter pipes.

Monitoring Real time production on SAP.

Machining experience Lathe, Grinding; Holiday Inspection; PLC; and Interlocks.

Classification of non conforming products into suitable categories, viz. Rework, down gradation, defective and

rejection in consultation with QA & concerned department heads.

EDUCATION, CERTIFICATIONS AND LICENSES

Process Validation for Medical Devices from CfPIE, 2013

Six Sigma Black Belt from American Society for Quality, 2011

Certified Internal Auditor from AQS Management Systems, 2012

Six Sigma Green Belt from Institute of Industrial Engineers, 2010

Acceptance Sampling for Manufacturing and Process Validation, 2013

M.S. (Industrial Engineering) from University of Texas, Arlington, Texas in 2009. (GPA: 3.8/4.0)

B.S. (Electronics Engineering) from JIIT University, India in 2007. (GPA: 3.6 / 4.0)

APICS Certification in Production and Inventory Management (CPIM)

ORGANIZATIONS

Tau Beta Pi Recording Secretary and Member, Texas Eta Chapter

American Society for Quality – Member

Institute of Industrial Engineers – Member

SKILLS

Value Stream Mapping, DMAIC, PDCA, SPC, PFMEA, DOE, JIT

Toyota Production System

Statistical Analysis – Minitab 15

Acceptance Sampling (AQL & RQL)

Microsoft Suite – Excel, Word, PowerPoint, Project, Outlook, and Access

Time & Motion Studies – MOST, MTM

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