Engineer Quality
Resume:
Dhaval Patel
******.*********@*****.***
PROFILE
Diverse experience in Cleaning Validation, Process Equipment Validation,
Risk Assessment, Change Control Management, Root Cause Analysis,
Corrective and Preventive Action, Site Validation Planning, validation
strategies and development of all related documentation.
Well versed with all stages of validation and software quality testing, 21
CFR (Parts 11,210,211) Validation, Remediation Plan, SOP Development, and
Qualification (IQ/OQ/PQ) Documentation.
. Excellent understanding of FDA regulations such as 21 CFR part 11, 50,
56, 58 210, 211, 820, PMA, 510(k), IDE.
. Expertise in validation deliverables such as Validation Master Plan
(VMP), Installation Qualification (IQ), Operational Qualification (OQ),
Performance Qualification (PQ), & Requirement Traceability Matrix (RTM).
. Experience in preparing SOP's, Validation Protocols, GAP Analysis,
Remediation plans & Corrective action & Preventive Action (CAPA)
investigation.
. Knowledge & experience working in cGMP, cGLP & cGCP environment.
. Strong on experience in using analytical lab instruments such as GC/MS,
LCMS, MALDI Imaging & a wide spectrum of other HPLC, UV/Vis, Ph Meters,
Autoclaves, incubators, Biological Safety Cabinet (Laminar Flow
chambers), Freezers, Function Generators, Oscilloscope, & Laser Scanning
Confocal Microscope.
. Experience in Failure Mode Effects Analysis (FMEA), ANOVA, Regression,
Design of Experiments (DOE)
. Excellent communication skills with strong analytical & problem solving
aptitude, coupled with demonstrated ability to complete tasks efficiently
in a fast paced, time sensitive environment.
. Excellent time management skills with the ability to prioritize projects
to meet deadlines.
TECHNICAL SKILLSET
CATEGORY DESCRIPTION
Engineering & Validation 21 CFR part 11,50,56,58,210,211,820 (IQ,OQ,PQ)
protocols, SOP's, RTM, LIMS, AERS, Audit
Trails, Gap Analysis, Remediation, Process
Design & Management, Improvement, ISO, Cleaning
Validation, Manufacturing Process Validation,
Equipment Validation, Computer Systems
Validation,
Laboratory Equipment GC/MS, LC/MS, MALDI/ESI, HPLC, Incubator,
UV/Vis, Autoclaves, laser scanning confocal
microscope, oscilloscope
PROFESSIONAL EXPERIENCE
Neutrogena Inc. (Working through Mason-Grey) (June'14-Current)
Validation Engineer III
Neutrogena is a cosmetic and OTC drugs manufacturing company and they have
a new CIP, SIP and COP system installed in the facility for WIP Tank,
Product Transfer Line and High Volume Filler. As I am the part of the
validation team which is responsible for the cycle development, validation
and summary report for this new installed system.
. Performed cycle development for the Tote transfer line and Product
transfer line.
. Independent and team based trouble shooting and investigation of the
issies which are affecting the cleaning cycle development and
validation.
. Generated reference documents and cleaning SOPs from validation
cleaning cycle.
. Wrote technical cleaning evaluation as requested, including MAR
calculation.
. Performed cycle development for the SIP system and prepare the summary
report.
. Prepared the recipes for the cycle development executed them.
. Sampling (Micro and Analytical).
. Prepared the document with the worst case sights(Visual Baseline) in
each line and sampled them.
. GDP review of the protocol written by other team members.
Janssen Pharmaceuticals, Inc. (Working through Hyde E+C) (July'12-May'14)
Validation Consultant III
Ben Venue Laboratories in Bedford, Ohio is manufacturing Doxil for Janssen
Pharmaceuticals. Doxil is an intravenous prescription medication to treat
multiple myeloma. There was a Doxil shortage in the market due to capacity
constraints of manufacturer. This capacity constraint was the reason of the
equipment failure. As working in the Hyde E+C, our goal was to validate the
cleaning process of BVL so we can eliminate the equipment failure and put
back the Doxil in the market ASAP. As a Validation Consultant III, I was
responsible for reviewing Cleaning Verification, Cycle development Protocol
and producing the Cleaning Validation Protocol for Parts Washer.
. Developed SOPs for TOC Swab, Visual Inspection, Conductivity Meter and
For GDP.
. Reviewed Cleaning Verification Protocol and upgraded it the changes
which can improve the cleaning of Vessels and Parts Washer.
. Sampled Parts Washer, Vessels and Manual Cleaned Equipments and
Submitted Those Samples to QC.
. Prepared Summary Report for the Cleaning Verification Protocol.
. Prepared Protocol for Visual Baseline of Vessels, Low Pressure Study
and Summary Report of them.
. Used MS Project for scheduling the cleaning and sampling for
Validation Runs.
. Worked Closely with Amicon Skid cleaning and Pump cart.
. Developed New Cycle for Parts Washer and from its successful
Implementation, we performed Validation of Parts Washer.
. Developed Method For TOC Swab and Prepared SOP for It.
. Developed Cleaning Validation Protocol for Parts Washer and Vessels.
. Found the Resolution Action for Discrepancies and Deviation during
these studies.
. Use Minitab for generating charts of Conductivity, TOC and Endotoxin
Results.
KVK Tech, INC (Dec'11- June'12)
Quality Consultant/Technical Writer
As company was scaling up the processes and developing a new facility for
packaging, I was the part of the Quality team and validation for the new
facility validation.
. Developed and executed the protocol for the scale up process.
. Developed the IQ (Installation Qualification) and PQ (Performance
Qualification) for New Tablet Compression system and V blender.
. Worked on the development on new packaging line.
. Authored and reviewed system user policy to comply with 21 CFR Part 11
requirements.
. Followed and maintained a rigorous cGMP training program.
. Managed the floor validation activities through supervision of operators
and provided assistance in SOP execution
. Maintained contact with the Vendor for system related
validation/calibration information and managed the vendor supported
installation and calibration of systems.
. Developed new cleaning process for the scale up process.
. As a part of Quality department, prepared SOP for the sampling for
tablets during the compression and blending.
Sanofi Pasteur Inc (Working through Manpower, LLC)(Feb'11- Nov'11)
Process validation engineer
As a Process Validation Engineer, was responsible for product transferring
from old facility to new facility and validated the process for new
products. I was also working on the parts washer cleaning cycle development
and on the freezer, refrigerators and hooded chambers.
. Developed, executed and reviewed Equipment validation protocols
(IQ/OQ/PQ) for freezers, incubators, hooded chambers, incubators,
fermentation tanks, Vapor Shippers, refrigerators, etc
. Conducted commissioning studies for some controlled temperature chambers
like freezers, refrigerators, hooded chambers,etc before validation
. Used Kaye Validator 2000 for thermal mapping of equipment, during
execution of qualification protocols and to generate qualification and
calibration reports
. Developing the Validation Production Plan executive summary reports for
completed campaigns to summarize the executed validation protocols,
Change over protocols, cleaning validations and equipment-related
protocols before and after the campaign
. Executed cleaning validation protocols involving Cleaning-in-place (CIP),
Cleaning-out of-place (COP), Sterilization-in-place (SIP),swabbing,etc
. Working in tandem with quality engineering to review/correct executed
protocols and then get them approved.
. Documented quality systems and programs in the areas of management
responsibility, auditing, quality trends, quality costs, training,
validation, design controls, purchasing controls, corrective and
preventive actions (CAPA), etc. to ensure compliance with FDA, and
regulatory requirements
.
EDUCATION
Master of Pharmaceutical Manufacturing, Stevens Institute of Technology,
Hoboken, NJ
Bachelor of Pharmacy, Ganpat University, Gujarat, India
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