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Ganesh Saigel
735 Bridgestone Drive, Apt-B, Oregon,
NA-52110 Phone: (320)721-9087, Email: ganesh.saigel87@gmail.com
OBJECTIVE: To obtain a position in a pharmaceutical
organization committed to producing Quality products for the well being of the community.
EDUCATION: Stevens Institute of Technology, Hoboken, NJ
Master of Science in Pharmaceutical Manufacturing,
DECEMBER- 2010 GPA: 3.63
Coursework: Good Manufacturing Practice in Pharmaceutical Industry, Bioprocess tech.
in API Manufacturing, Validation and Regulatory
affairs in Pharmaceutical Industry, Contemporary Concepts in
Pharmaceutical Validation, Design and Management of Sterile Pharmaceutical
Manufacturing, Introduction to Project Management, Computerized System Validation,
Engineering cost and economics. Regulation and Compliance in Pharmaceutical
Industry
Pune University, Maharashtra, India
Bachelor of Pharmacy MAY- 2008
GPA: 3.80
SKILLS:
Lab Skills: Rheometer, Contact lens Analyzer (clan
Study), Lens thickness Gauge, knowledge of Light stream Technology, Dynamic
Vapor sorption for dehydration study, Knowledge of Solvent Exchanger, Bench
Chemistry practice, PH meter, TOC
Analyzer, UV-Visible Spectrophotometer, Karl Fisher, HPLC, wet chemistry analyses, HPLC, IC, IR,TLC,GC, Titration, Assay Analysis,
Disintegration, Dissolution Apparatus, Tablet Manufacturing and Coating, Microbiological
Assays, Knowledge of Swab sampling, Cleaning Validation and Sanitization
technique, Sterile Facility design.
Software
Skills: Windows
XP/ Vista/ 7, Microsoft Office 2003
and 2007, Microsoft Project 2007, Statistical
Software-Minitab 15
Communication
Skills: Fluent in
written and spoken: English, Gujarati, Hindi and Marathi.
PRESENTATION:
·
Blow
Fill Seal Technology
·
Six
Sigma in Pharmaceuticals Industry
·
Use of
Scenario with Prototype to Validate analysis and design
·
Chromatography an Important Technique in API Production.
·
US-ANDA submission – requirement and strategy
·
FDA Foreign Inspection.
PROJECTS:
HBD
Validation Project
·
Prepared
SOPs for various equipments and processes, Training records for SOPs,
Laboratory Reports.
·
Failure Mode and Effects Analysis, Gage R&R, Risk Analysis, Validation Master Plan, Quality Policy, Calibration and Maintenance
Record, Quality Audit, Master batch record, Process Flow Diagram, IQ, OQ, PQ
and Design of
Experiments for cleaning,
blending process,
Statistical Quality Control, Statistical Process Control.
·
Derived
at results using graphs using statistical software Minitab and identified
sources of variation by interpreting graphs and results.
BOD
A for Sterile Facility (Oncology Drug)
·
Proposed
three different sites for manufacturing of new potential sterile blockbuster
drug
·
Provided
options for different technologies that can be used for production and
calculated capacity analysis for each option and developed FAT and SAT
protocol.
·
Developed
design for manufacturing area, flow of material, man and air.
EXPERIENCE:
Ø CIBA Vision Novartis (ALCON), Johns creek, GA [April-11-Present]
Associate Scientist- Friction Testing of Contact
Lens (Medical Device)
·
Optimized the Friction Testing Method (Derby Test)
of contact Lens for Lubricity study of contact Lens.
·
Test the Friction of New Contact Lens and Compared
with Other Commercial Lenses.
·
Data Collection, Analysis of Data from Minitab,
Interpreting the Graph, Prepare Final Report of study.
·
Fribrication of Contact Lens by Light Stream
Technology, Extraction, Coating, Inspection of lens for any Defect by shadow
microscope, CLOGA for Research study.
·
Making the Different Coating solution in Bench
chemistry and coating the contact lens and record keeping.
·
Study to find way how to find the thickness of coating on lens.
·
Dynamic Vapor sorption study to find the solvent
which can decrease the evaporation rate of tear solution.
·
Clan study to find the uniform coating on lens , Contact
lens water content study.
Ø
Macleod’s
Pharmaceuticals, India [June
- July 07]
Manufacturing and Testing Department,
·
Performed raw material testing, dissolution,
disintegration, Qualitative and Quantitative analysis
Using HPLC, HPTLC, GC and IR and Chemistry test
like PH meter, Viscosity as well as titrations.
·
Performed
validating procedures for raw materials in process, validation, product
inspection, finished product and stability tests.
·
Observed, manufactured, prepared reports
of all tests in Testing Department as part of a team.
·
Documented
all results in agreement with cGMPs and written procedures and reported all
observations.
·
Monitored
different sections of operations like granulation, compression, coating,
packing, capsules manufacturing for the final product stability studies.
Ø
J.B
Chemicals and Pharmaceutical, India [June-January
08-09]
Quality Assurance Department
·
Checked the Quality of the Drug Product while In
process of Manufacturing for the Assurance and Quality control, and documented
the respected Result As per GMP and FDA regulation in Document
·
Performs
batch record review & approval based on specifications and procedural
requirements and Evaluates &
approves change controls Any Deviation in the process is reported in
Deviation report
·
Validated Master
Plan for on-time start-up of facility
operations and validation of existing facilities, in compliance with GMP
requirements and Quality of product is recorded.
·
Deal with the record keeping of all document related
to Drugs, batch Packaging, batch Manufacturing and any change control.
·
Evaluates
& approves quality deviations along with associated CAPAs for quality
standards & process controls
·
Reviewed change
to equipment, facilities, and processes for validation requirements.
·
Gained knowledge of Document Review,
Process Validation and GMP Checking.
SEMINARS:
·
Recovery
of Insoluble Compound using TOC
·
Cleaning
Validation Study Using SLS
REFERENCES: Available upon request.
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