Quality Engineer Engineering
Resume:
Meghna
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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