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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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