Manufacturing Six Sigma
Resume:
VILAS DUDHAT
North Brunswick, NJ 08902
Cell: 732-***-****, acql6t@r.postjobfree.com
OBJECTIVE:
Seeking a Challenging position in pharmaceutical industry where I am utilize my skills and experience in the areas of Formulation or validation.
EDUCATION:
M.S in Pharmaceutical Manufacturing Engineering (Jan 2010 - Dec 2011)
Stevens Institute of Technology, Hoboken, NJ
Relevant Courses: Contemporary Concepts in Pharmaceutical Validation, Validation and Regulatory Affairs, GMP in Pharmaceutical Facilities Design, Quality in Pharmaceutical Manufacturing, PAT in pharmaceutical manufacturing, Regulations and Compliance in Pharmaceuticals, Lean six sigma in pharmaceutical manufacturing, project management, pharmaceutical packaging.
B.S in Pharmacy (June 2004 –April 2008)
L.J Institute of Pharmacy, Gujarat, India.
Relevant Courses: Pharmaceutical engineering, Pharmacology, Medicinal and pharmaceutical chemistry, Microbiology, Pharmaceutical analysis, Pharmacognosy, Anatomy physiology and health education.
SKILLS:
Laboratory /Technical Skill: Formulation and evaluation of pharmaceutical products, Dissolution, Disintegration, Swab sampling, Total Organic Carbon (TOC) Analyzer, pharmaceutical analysis, UV, Cleaning validation, Root cause analysis- Fish bone diagram, run charts, process control chart, histogram, process capability, PAT, QbD, Lean Six sigma manufacturing, Risk Assessment, FMEA.
Manufacturing Skills: Pharmaceutical machineries-Tablet press equipment, Capsule filling equipment, Granulating equipment, Coating equipment, Blending equipment, Milling equipment.
Software Skills: Excellent in use of Microsoft word, Excel, Power point, Minitab 16 statistical software,
M-files, Empower II
ACEDEMIC PROJECTS:
Presentations:
“Facility design for sterile lyophilized powder product.”- Facility layout, Equipment specification.
“Compliance risk management using top down validation approach.”
“Pharmaceutical quality by design”- Design space, PAT (process analytical technology).
“Cleaning Validation for Developmental, Stability and Clinical lots”, research various cleaning processes, developed VMP for Cleaning Validation.
WORK EXPERIENCE:
Novel Laboratories, Somerset, New Jersey
Analytical Scientist-II/Validation Engineer (March 2013-present)
Expertise in technical writing and reviewing of Validation documents such as Validation plan, Validation Protocol (IQ, OQ, PQ), Validation final reports and Laboratory documents such as Instrument logbooks, Laboratory record books, Certificate of analysis.
Experienced of cleaning validation (Spiking, Swab sampling and TOC analyzer, Analysis of data)
Process development by Design of Experiments (DOE), Performed statistical analysis by Minitab, calibration of instruments, risk assessments and FMEA.
Generated and Executed IQ, OQ and PQ protocols for the Lab Equipment: HPLC, GC, Desitometer, Titrators, UV-Visible Spectrophotometers, TOC Analyzers, Particle Counters, Design Qualifications (DQ) documents for the Lab Equipment.
Documentation Tracking and Scheduling Validation Activities
Performed risk assessment and requalification of Dionex-600 Ion Exchange Chromatography.
Responsible for change control assessment and CAPA related to Laboratory Equipment Qualification.
Performed different tests such as Assay, Related Compounds, Content Uniformity, Blend Uniformity, Loss on Drying, Dissolution, Identification Studies, Moisture Content, and Disintegration.
Cleaning Method Development and Method validation
Developed and validated method for the analysis of related substance, assay, and dissolution.
Performed analytical tasks as assigned for development, responding FDA deficiencies, and other laboratory testing.
Proficient in Operation of HPLC, GC, UV/Vis, FTIR, Karl Fischer, pH Meter, Dissolution (basket/paddle).
Experience of processing and reporting UPLC, HPLC and GC analysis using Empower II
Swab sampling for cleaning validation at manufacturing site.
Performed testing on Raw materials, In-process, Finished products and Stability Samples
Record all the information and data as per cGMP.
Experience of working under current Good Manufacturing Practice (cGMP) and GLP environment
Calibration of instrument like pH meter, Balances and Karl Fisher, Dissolution Apparatus and HPLC
Johnson and Johnson, Skillman, New Jersey
Formulation Scientist (February 2012-February 2013)
Working with special products like semisolid and liquid formulations as formulation scientist in Specialty product development at Johnson and Johnson.
Scientist in a specialty product development group and working with various dosage forms 1) semisolid products like creams, ointment, lotions, gels, foams and dental paste. 2) Liquid products like solution, syrups, suspensions etc.
Applying DoE in development of formulations and processes according to FDA's QbD requirements.
Preparation and writing of SOP’s, batch records, packaging component specification, investigations, technical protocols and reports, process/verification/cleaning protocols and reports
Support the Process Capability work associated with the Supply Chain Reliability Effort
Uses the principles and theories of science and mathematics to solve problems in R&D and to help invent and improve products-processes
Coordinate activities with Product Development, Manufacturing, analytical department.
Coordinates testing responsibilities to ensure QA test support according to the needs of Manufacturing to maintain continuous process flow
Investigates testing abnormalities and implements corrective action
Determination of root causes of non-conformances and recommends corrective actions
Responsible for the review of finished product release specifications and stability specifications
Assists with special projects by supporting the development of new test methods of performing investigative test analyses as required
Assists in projects including the validation of test methods and transfer of new products-processes-test method
Statistical analysis and determination of specification ranges for actives based on process capability data, Accelerated study data and marketed product stability data by using Minitab software
Performing change control using global change control (GCC) system for investigation of out of specification (OOS) & out of trend (OOT)
Supporting post launch product
Working under current good manufacturing practices (cGMP) and following Good laboratory practices (GLP)
Validation Engineer, Qualification/Validation Project,
Stevens Institute of Technology (August 2011-December 2011)
Develop process validation protocols and reports
Optimization of various process parameters using statistical tools like DOE (Design Of Experiment), Process Capability, Accuracy and Precision, Process control and Gage R&R and ANOVA using Minitab16 statistical software, Lean six sigma manufacturing
Investigation of out of specification results CAPA.
Coordinate with different department to achieve project milestone
Developed Master batch record, Validation protocols(IQ,OQ,PQ)
Reviewed developmental studies, SOPs,lab reports and risk analysis documents
Developed FMEA for design, process and equipment
Prepared and maintained logbook according to GMP standards
Prepared SOP and Validate Spreadsheet for the Content Uniformity
Developed and Validate swab sampling method using TOC analyzer for cleaning validation
Provide support to ensure main manufacturing processes and support processes are validated and in compliance with requirements.
Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
Understanding of Validation Development Lifecycle, Process and Cleaning Validation, Computer system validation, Risk analysis by FMEA, DOE (Design of Experiment), Audit Trail, pharmacovigilance.
ACTIVITIES
INTERPHEX – 2010-2011
IPC – 60th “Indian Pharmaceutical Congress” - 2008
Industrial visit- Genzyme biopharmaceuticals
Affilation: Registered Pharmacist in Gujarat State Pharmacy Council
Certificates: Validation and regulatory affairs, Pharmaceutical manufacturing practices.
REFERENCE
Available upon request
Contact this candidate