Validation Specialist III

Objective: - To pursue a position by improvising and applying present skills which can be helpful to update my experience and ultimately it will positively reflect on company’s profile in future.

Education:-

Master of Science in Pharmaceutical Manufacturing.

Stevens Institute of Technology, Castle point on Hudson, Hoboken, NJ-07030, USA, Graduated in December 2010.

Bachelor of Pharmacy.

L. B. Rao Institute of Pharmaceutical Education and Research, Khambhat, Gujarat University, Gujarat, India, Graduated in May 2008.

Professional Experience:-

VALIDATION SPECIALIST III, AT STERIS LABORATORIES, MINNEAPOLIS, MINNESOTA, USA (OCT’14 TO PRESENT)

Writing and executing protocols (IQ/OQ) to support qualification of equipment such as Microscope, Glassware Washer, Ultra sonicator, Incubated Shaker, Weighing Balance, pH meter, System 1E Liquid Chemical Sterilant Processing System etc.

Responsible for preparing, executing and/or reviewing qualification protocols for various Temperature Controlled equipment like Sterilizer, Walk in cooler, Freezers, Refrigerators, Incubators, Oven, Liquid Cryo Bath, Liquid Nitrogen Cryo system using Kaye Validator.

Participated in preparation of Validation deliverables includes start-up procedures, commissioning documents, process validation, cleaning validation and final summary report.

Responsible to oversee the qualification pertaining to the utility systems includes USP Purified Water, USP WFI, Clean Compressed Air and Clean Steam.

Assist in the production of user requirements, specifications, standard operating procedures and other documentation required for the completion of the validation.

Responsible for providing technical support and technical expertise to project team to facilitate resolution of system and quality issues and other GMP documentation.

Responsible for preparing Equipment Management Plan (EMP) and Failure Mode and Effect Analysis (FMEA), risk assessment in support of validation activities and manage issues related to CAPA.

Maintain knowledge and comprehensive understanding of relevant pharmaceutical and Medical Devices regulations, GMP, GLP, USP Guidelines, 21CFR Part 11 and current interpretations affecting equipment, product, process and cleaning validation.

MANUFACTURING / VALIDATION SPECIALIST, AT HEMISPHERX BIOPHARMA INC., NEW BRUNSWICK, NEW JERSEY, USA (OCT’11 TO OCT’14)

Written Validation protocols IQ/OQ/PQ and Test Protocols to support qualification of equipment and provide technical support in Commissioning, Qualification and Validation (CQV) Program.

Executed Validation IQ/OQ/PQ protocols for Autoclave (Steam sterilizer), Mixing tanks, Walk in coolers, Freezers, Incubators, Bioreactor and various other equipment using KAYE VALIDATOR.

Executed IQ/OQ for Floor Scale, pH Meter, Weighing Balance, Peristaltic and Centrifugal Pumps, Glassware Washer, Compressed Air, Boiler etcetera.

Performed and developed CLEANING VALIDATION study on Formulation Tanks and Process vessels. Riboflavin Coverage study, soiling, Swab and Rinse Sampling were performed to support such cleaning validation study.

Worked on facility scale up project of CIP/COP and SIP design of bioreactor, Viafuge Centrifuge and other formulation tanks.

Performed and optimized downstream processes of Depth filtration (Collection of Crude Cells), Stirred cell and/or Tangential Flow Filtration (TFF).

Written SOPs, Batch records, Facility Cleaning/Sanitization Protocol and other regulatory documents.

Performed and optimized operations of bioreactor which grows and promotes cell induction and have been part of FAT of 600L bioreactor.

Performed Affinity chromatography by using NK2 antibody and Size exclusion chromatography by using superose column to support downstream processes.

Actively Participated in Process development of PNPase enzyme used in manufacturing of Polymers and produce pilot Polymer batches complying GMP standards.

Worked on Water system operation and maintenance, operated TOC analyzer and used routine laboratory instruments like pH meter, conductivity meter, weighing balance, turbidity meter, viscometer etcetera

TRAINEE, INTERNSHIP AT CADILLA PHARMACEUTICAL, GUJARAT, INDIA (MAY 2008 - JULY 2008)

Trained routine analysis using established techniques like HPLC, UV & IR following published methods and SOPs and assisted in laboratory testing (raw materials, intermediates, final container, and stability) under general supervision.

Assisted microbiological assay and also dealt with microorganisms, aseptic technique. Also performed microbial validation of bio burden, sterility in accordance with validation protocols.

Manages information on raw materials and vendors and also manages information on finished product shipments and product retains.

TRAINEE, INTERNSHIP AT PRIYAL PHARMA, GUJARAT, INDIA (MAY 2007-JUNE 2007)

Assisted in Sample preparation includes performing methods such as soxhlet extraction, solid phase extraction (SPE) and liquid liquid extraction.

Troubleshooting equipment to meet hardness, thickness, and diameter tablet specifications with appropriate API (Active Pharmaceutical Ingredient) concentrations.

Analytical and preparative scale chromatography and Performed tests including Karl Fischer water determination, Thin Layer Chromatography (TLC) and viscosity measurement on raw materials.

Certificates and Professional Affiliations:-

Certificates of Hazardous materials (HAZMAT) regulations in compliance with section 172.704 (a) (1), of the 49CFR.

Pharmaceutical manufacturing practices graduate certificate.

Bio process system in pharmaceutical manufacturing graduate certificate.

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