Quality Control Supply Chain

HITESH VERMA

Phone:- 843-***-****

*************@*****.***

SUMMARY

• Over 3+ years of experience in life science in Biotechnology / Pharmaceutical and Clinical

Research Industry.

• Throughout Understanding of Good Clinical Practice( GCP), Good Manufacturing Practice (GMP

), and Good Laboratory Practice( GLP).

• Good Knowledge of Ethics in Clinical Research, Regulatory Requirements FDA and Drug

Control.

• Good Knowledge of Health Insurance Portability & Accountability Act (HIPAA).

• Experience with Bio- Analytical and Bio- Equivalence guidelines.

• Good understanding of Investigation New Drug Application (IND) and New Drug Application

(NDA) in Therapeutic Products Directorate (TPD).

• Good understanding of Pharmacovigilance, Fraud, Misconduct, Reporting and Documentation.

• Basic knowledge of HIPAA 4010, 5010 and ICD 9 to ICD 10.

• Familiar with buffer preparation, titration, pipetting, pH meter and Analytical Balances.

• Experienced with Cell Culture techniques, Egg Culture Techniques.

• Experience with Ion Exchange, Column Chromatography with AKTA Explorer, AKTA Pilot,

AKTA Process, and TFF (Tangential Filtration Flow) (Cogent M Millipore on different Kda

cassettes).

• Experience with Fermentor-20 lts, 750 lts. CIP and SIP of tanks-500 lts.

• Experience in Preparation of Master Formulae and SOPs related to the process.

• Experience in filling of Batch Manufacturing Records on a regular note.

• Experience in filling of Change Controls, Incident Reports, and Deviations etc.

• Very sound Knowledge of performing IQ, OQ and PQ of equipments.

• Experienced in evaluating vendor performance to ensure adherence to predefined specifications

and supply of quality material / execution of job works.

• Encompassing knowledge of Software Development Cycle (SDLC) and quality control methodologies

such as Waterfall, Agile & Scrum.

• Expertise in broad range of technologies, including business process tools such as Microsoft Project,

MS Access, MS Visio, MS PowerPoint, MS Word

• Excellent presentation skills including verbal and written skills, and flexibility in adapting to new

relevant information and changes

• Experienced cost saving and energy saving techniques.

• Excellent blend of organizational, decision-making, and communication skills,Effectively

collaborates with team members to meet or exceed expectations, Quickly adapts to new roles,

environment, and responsibilities.

TECHNICAL SKILLS

• Ion Exchange chromatography.

• Column Chromatography with AKTA Explorer, AKTA Pilot, AKTA Process, and

• TFF (Tangential Filtration Flow) (Cogent M Millipore on different Kda cassettes).

• Filtration, Particle Monitoring, and Filter integrity test.

• IQ, OQ and PQ of equipment’s.

• Molecular techniques including DNA, RNA isolation, SDS-PAGE, Spectrophotometry.

• Polymerase chain Reaction, RFLP, DNA fingerprinting, Electro blotting.

• Buffer preparation, Media preparation, pH balancing.

• Cell culture, Tissue culture.

• GE 750/1500 L fermenters Validation.

• Software Development – SDLC, Waterfall, Scrum, Agile

• OS – Unix, Mac, Windows, Linux

• Diagramming Techniques – UML – Use case, Basic Process, Dataflow Diagram, Activity Diagram,

• Data Analysis Tool – MS Excel, MS Access.

• Office Automation – MS Project, MS Word, MS Excel, MS PowerPoint, Outlook

• Upstream and Downstream Processing.

• ELISA

• Faced DCGI and WHO Audits.

• REDCAP

• SAS

• SAP- Sales and Purchase.

• SCM- Supply Chain Management

• LANGUAGE C

CERTIFICATIONS

• Certified in Clinical Research Ethics.

• CITI MIAMI Certified.

• HIPAA Certified.

EDUCATION

• Masters Of Science In Clinical Research from Medical University Of South Carolina (2011-2013)

• Bachelors of Technology in Biotechnology from Kurukshetra University, India (2005-2009)

EXPERIENCE

PANACEA BIOTEC LTD. INDIA

OCT 2009 TO OCT 2011

• Monitored the production status, procedures and systems followed in egg based viral vaccine

production to ensure compliance of norms with desired quality and timely achievement of target.

• Successfully completed clinical trial batches for Seasonal Flu Vaccine and commercial batch

production of one million doses of Influenza Vaccine.

• Efficiently prepared Master Formulae and SOPs related to the process.

• Well versed with Egg Culture and Cell Culture Techniques.

• Operated Ion Exchange, Column Chromatography with AKTA Explorer, AKTA Pilot, AKTA

Process, and TFF (Tangential Filtration Flow) (Cogent M Millipore on different Kda cassettes).

• Operated Fermentor-20 lts, 750 lts. CIP and SIP of tanks-500 lts.

• Performed Sterile Filtration, Particle Monitoring, and Filter integrity test.

• Exercised Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) along

with safety measurements.

• Preparation of Master Formulae and SOPs related to the process.

• Ensure filling of Batch Manufacturing Records on a regular note.

• Filling of Change Controls, Incident Reports, and Deviations etc.

• Performing IQ, OQ and PQ of equipment’s.

• Perform many tasks on software development with the vendors related to Autoclave, Fermenter

Software.

• Consistently evaluating vendor performance to ensure adherence to predefined specifications and

supply of quality material / execution of job works.

• Implementing cost saving and energy saving techniques and modifications to achieve substantial

reduction in Organizational & Management expenditures and work within the budget.

U.I.E.T, KURUKSHETRA UNIVERSITY, INDIA

JAN 2009 TO JUNE 2009

Comparison of different methods Genomic DNA Extraction from Asparagus

• Worked on different methods of DNA extraction like CTAB Method, Phenol Chloroform Method

and DNA isolation by standard kit.

• Worked with Waterbath, Centrifuge, Micropipettes, pH meter, Weighing Balance, UV Trans

illuminator, Electrophoresis etc.

• Evaluate the Extracted DNA by Agrose Gel Electrophoresis.

• Prepared a Literature Review related to DNA extraction.

• DNA extraction was done on Medicinal Plant (ASPARAGUS).

U.I.E.T, KUK, INDIA

AUG 2008 TO DEC 2008

Optimization of DNA Extraction from LEMON GRASS (Cymbopogan Citratus).

• Performed preparation of root slips, planting, Fertilization, Irrigation, Weeding and Interculture

and Harvesting.

• Performed Oil Extraction from the wilted herb by steam distillation in stainless steel unit.

• Prepared a literature review related to Lemon Grass.

• Worked with Water bath, Liquid Nitrogen, Gel Doc., and Pestle & Mortar.

• Performed RNAse Treatment.

• Evaluated the Extracted DNA by Agrose Gel Electrophoresis.

G.N.D.U AMRITSAR, INDIA

APRIL 2007 TO JULY 2007

Prevalence of obesity and hypertension in newly diagnosed type 2 Diabetes Mellitus in patients of

Amritsar.

• Worked with undergoing project for the prevalence of obesity and hypertension in newly

diagnosed type 2 Diabetes Mellitus.

• Collected the blood samples of patients from different hospitals.

• Perform Fasting Glucose Test, Casual Plasma Glucose Test, and Oral Glucose tolerance test.

• Performed highly invasive biochemical tests (FPG, OGTT, HbA1c, fructosomine, random plasma

glucose, etc.)

VERKA MILK PLANT, INDIA

MAY 2006 TO JULY 2006

• Performed the Quality Tests for Milk Products.

• Ensures the maintenance and standards of specification and standard of products within the

tolerance limit.

• Performed Acidity Test, SNF test, Fat Test, MBRT test and Adultration Test.

• Performed GERBER’s Method for Fat and SNF Test.

• Performed Phosphatase Test for pasteurization of milk, Salt Test, Urea Test.

• Performed Curd acidity Test, Hardness of milk Test etc.

• Worked on Pasteurizer, Homogenizer, Cream Separators, Storage Tanks etc.

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