SUMAN NALLA

ac1tif@r.postjobfree.com, 309-***-****

Available start date – 07/10/2017,

***** ******** ****, *********, ***** Carolina, 28262

SUMMARY:

Progressive experience as a Quality/Validation Engineer in product design and manufacturing environment. Extensive experience in Product Development and Tool Design. Developed and performed individualized and group training to maintain quality and regulatory compliance. Experience includes complaints investigation/handling, CAPA, 21 CFR 210, 211, 803, 806, 820; ISO 13485, ISO 14971, post-market surveillance.

TECHNICAL SKILLS

Product Life Cycle Management, Change Control, Design History File, Verification/Validation, Risk management activities (Hazard Analysis, Fault Tree Analysis, Use FMEA and Design FMEA), MS Office, cGMPs, Design Controls, Risk Management, CAPA, Post-market Surveillance, Writing Validation Protocols- IQ/OQ/PQ/ SOP’s, Process Validation, Master Validation Plans, Pro-E, Remediation, PFMEA, 21 CFR Part 820 - Quality System Regulation (QSR), FDA and Gage R&R.

PROFESSIONAL EXPERIENCE

Validation Engineer

Express Scripts Inc– Accenture services pvt ltd 16th Aug’12 – 31st July’15

Led CAPA/TMV project. Improved CAPA system performance by reducing oldest open CAPA.

Collaborated with engineering and operations to develop test methods and fixtures for incoming materials as well as finished goods.

Authored various Test Method Validations (Gage R and R using Minitab) and performed Root Cause Analysis on various issues pertaining to CAPAs and NCRs.

Performed DFMEA and PFMEA Analysis. Performed GAP Analysis of existing Risk Management Plans and suggested Remediation activities. Created Design History Files.

Worked closely with customers and suppliers to resolve quality related issues and concerns.

Authored process validation (PV) protocols and reports (IQ/OQ/PQ). Gap analysis of legacy documentation to meet external/internal standards. Execute approved process validation (PV) protocols using validated test method

Knowledge of PFMEA (risk, severity, occurrence, detection).Author Technical reports, Equipment and Material Specifications.

Ensure the execution of equipment safety assessment, environmental impact assessment, preventive maintenance, and calibration for successful completion of IQs.

Apply knowledge of CAPA to improve Manufacturing Procedures. Conduct process capability studies, and time studies to improve processes.

Working knowledge of transferring design specifications into manufacturing specifications.

Work closely with R&D, Quality and Regulatory functional groups. Advanced computer skills, including statistical/data analysis (such as normality assessment, k-factor, t-test, safety factor, process capability, etc.).

Assist in developing and execution of test method validation (TMV).

Create training plans for supervisors and operators on improved process steps. Troubleshooting on process lines to make sure smooth equipment functionality .Work with external vendors to meet production needs.

EDUCATION

Masters in Mechanical Engineering, Bradley University, IL Aug’ 15 – May’ 17.