Meghna

301-***-****

SUMMARY:

. Experience in pharmaceutical industry with solid knowledge on FDA 21 CFR

Part 11: Electronic records and Electronic signatures, 21 CFR Part 50,

**, **, ***, ***, 312, 314, 820

. Quality Engineer experience in analysis of corrective action, process

development, quality improvement and cost reduction efforts.

. Highly experienced in conducting Manufacturing and Laboratory

Investigations for Out Of Specifications, Root Cause Analysis (RCA),

Gap/Risk Management, Change Management, Balanced Scorecard, Failure Mode

and Effect Analysis (FMEA), Statistical Process Control (SPC), Analysis

of Variance (ANOVA), Quality by Design (QbD), and Design of Experiment

(DOE).

. Well experienced in preparing documents for Computer System Validation

(CSV) lifecycle, including Validation Master Plan (VMP), IQs, OQs, PQs,

Standard Operating Procedures (SOPs) and Validation Summary Report (VSR).

. Excellent experience in Validation of Computer applications such as

Sample Manager, Documentum, LIMS, CMMS applications, Recon in Compliance

with 21 CFR Part 11.

. Excellent knowledge and experience of analytical lab instruments such as

GC/MS, HPLC, Spectrophotometer, Autoclaves and Flow Cytometer

. Well versed with the development and maintenance of Requirements

Traceability Matrix (RTM)

. Excellent interpersonal, organizational and communication skills

SKILLS:

Computer System Validation 21 CFR Part 11(50, 56, 58),

Validation Protocols (IQ, OQ, PQ),

cGxP (GLP, GMP, GCP), SOP, Gap

Analysis, Remediation Plans, Audit

Trails, RTM

Computer Language SQL, VB, SAS, Matlab, C, C++,

Maple, AutoCAD

Operating system Windows OS, Vista

Testing and Tracking Tools Quick Test Professional, Quality

Center

Analytical Software LIMS, AERS, EMPOWER TrackWise

Databases Oracle, MS SQL Server, Sybase

Central

Laboratory Equipment HPLC, Spectrophotometer,

Autoclaves, pH meters, humidity

controllers, Freeze Dryers, and

incubators

WORK EXPERIENCE:

Client

Jan 2011 - Present

Quality Engineer

As a Quality Engineer I was responsible for designing and conducting

training on compliance issues like Risk Analysis/Management, Failure Mode

and Effect Analysis (FMEA) and Corrective Action/Preventive Action (CAPA).

. Responsible for Quality documentation, Risk Analysis activities including

FMEA and PFMEA's (failure mode analysis), Investigation and CAPA of

quality/production issues, Solving specific manufacturing problem or

quality issue, Gap analysis and risk analysis

. Develop and update Quality Plan, Risk Analysis, Hazard Analysis, and FMEA

(Design and Process). Support Design Changes & Product Introduction

following PDP & Design Controls Principles

. Worked closely with Business users, SME's (Subject Matter Experts),

Business intelligence team, development and testing team to make sure all

the Business / System Requirements are being met during implementation

phase.

. Involved in creating Design Specification and Detailed Design Documents,

while working closely with the developers.

. Coordinated with SMEs, Scientists, team members and personnel across the

board to develop and update technical documents, SOPs, Work Instructions

and Guidelines.

. Conducted walkthroughs, V&V, system testing, GUI and functional testing

and back end testing.

. Created test plan, test cases and test scripts

. Performed Regression testing to ensure reproducibility and Data Driven

testing to ensure Data Integrity.

. Involved in GAP analysis to ensure adherence to all user requirements and

devised Remediation Plans.

. Prepared Validation Summary Report (VSR).

Client

Mar 2009 - Dec 2010

Quality Engineer

. Responsible for Quality Engineering support in the creation and

development of Class II implantable medical device products in compliance

with 21 CFR Part 820 and ISO 13485.

. Performed Verification/ Validation (V&V) for surgical implants and

instrumentation sets. Wrote protocols and reports for FDA filing

including: Sterilization, Cleaning, and Shipping.

. Performed risk analysis and application of cGMP for process or products

using FMEA tools.

. Participated in analyzing Process/Design Failure Mode and Effects

Analysis (FMEA) and technology transfer.

. Reviewed and approved test protocols and reports for process operational

and performance qualifications (OQ/PQ) and product Design

Validation/Verification.

. Utilized risk tools such as FMEA, Hazard Analyses, and Risk Management.

. Performed CAPA root-cause analysis, investigation and resolution

planning.

. Change Control Board: Created, reviewed, edited, and approved Change

Orders to support R&D, Manufacturing, Regulatory Affairs, and Quality

improvements using Agile software.

. Wrote or reviewed, improved, and approved Operating Procedures.

. Authored Quality Inspection Plans used by Quality Control.

. Performed risk analysis assessments using the FMEA approach

Client

Mar 2007 - Mar 2009

Quality Engineer

. Conduct process validations for a leading medical device manufacturer,

which activities included writing and executing protocols for all steps

in the validation process.

. Perform Process Engineering and Six Sigma DMAIC activities which include

the following: process capability studies, design of experiments (DOE),

process maps, cause and effects matrices, PFMEA's, SPC, Measurement

System Analysis (MSA)/Gage R&R, ANOVA.

. Supported completion of Quality Engineering deliverables associated with

new product development activities. Worked with R&D and Manufacturing

Engineers to develop and maintain quality standards for new product.

. Created and maintained Risk Analysis documentation, including Failure

Modes and Effects Analysis (DFMEA, CFMEA, PFMEA), Fault Tree Analysis

(FTA) and accelerated life testing for new medical devices.

. Wrote and executed test protocols and reports, reviewed and approved

technical data, supported engineering builds and participate in project

team meetings.

. Performed detailed Design/Process FMEA, DOE and analyze results using

statistical methodology. Led failure analysis to determine root cause and

corrective action.

. Supported IQ, OQ, PQ studies (supported development of protocol,

discussed challenges, FMEA, supported tests, and builds).

. Updated FMEA and related risk assessment documentation

. Performed risk management/assessment activity, hazard analysis, root

cause analysis, Customer Compliant Action (CCA).

. Utilized risk tools such as FMEA, Hazard Analyses, and Risk Management.

. Worked with Business Analysts and gathered and assembled Business

requirements and User specifications

EDUCATION

Master of Science, Biomedical Engineering Duke University

Bachelors in Engineering, Biomedical Engineering Vishveshvaraya

Technological University

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