Quality Control Manufacturing

JIGNESH SHAH

Chemist

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

Summary

More than 2 years of experience in a Quality Control department as a Chemist I in Pharmaceutical company

Proficient in HPLC (Waters and Agilent), FTIR, UV-Vis, Dissolutions techniques, Disintegration, Hardness

Tester, Friabilator, pH meter, Analytical Balances

Capable in data processing with Empower 3 and Totalchrom data processing systems

Actively participated in giving training to new &/ junior chemist on dissolution techniques as well as HPLC

(use and processing)

Hold a certificate of “Validation and Regulatory Affairs in Pharmaceuticals” while pursuing Master’s of

Science degree at Stevens Institute of Technology, Hoboken, NJ

Ability to learn and adapt to new domains and new technologies very quickly

Excellent knowledge of Computer System, MS Office 2007(Excel, Word, Power Point)

Knowledge of QA tasks such as document control, GMP Compliance, GMP Auditing, standards development,

training systems, CAPA, Validation, change contro etc.

Experience

Chemist at Norwich Pharmaceuticals

March 2011 - Present (2 years 4 months)

• Proficient in testing for Finished products (Solid Dosage forms- Tablets and Capsules) and Cleaning

Verification of Manufacturing Equipments by using HPLC (Waters and Agilent), FTIR, UV-Vis spec,

Disintegration, Hardness Tester, Friabilator, pH meter, Analytical Balances, Karl-Fisher and Atomic

Absorption

• Skillful and Attentive to details in performing analytical methods like Dissolution, Related Substance,

Assay- Related Compounds and Impurity testing, Content Uniformity and Blend Uniformity of Solid Dosage

Forms

• Performed testing and real time documenting procedures as well as results strictly as per GLP/cGMP in a

legible manner following established formats and procedures

• Calibrated Laboratory instruments, troubleshoots instrumental problems and maintained their records,

Wrote and Review technical documents like Methods and Calculations

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• Training of new/junior chemists in lab about SOP, GLP and Data processing via Empower 3

Product Analyst at Alpine Health

February 2010 - March 2011 (1 year 2 months)

Responsible for performing supplier research for API and finished dosage products

Followed FDA and cGMP guidelines in maintaining consumer and product safety

Prepared and approved documentation on new product approvals and recalls

Wrote and followed SOP's for daily activities performed in the state of the art facility

Courses

Bachelor of Science, Pharmaceutical Sciences

HNG University

Pharmaceutical science

Pharmaceutical Chemistry

Pharmacology

Master's of Science, Pharmaceutical Manufacturing

Stevens Institute of Technology

Validation and Regulatory Affairs

Pharmaceutical Manufacturing

Project Management and Statistical Analysis

Bachelor's of Science, Pharmaceutical Science

Hemchandracharya North Gujarat University

Pharmaceutical Sciences

Languages

English (Full professional proficiency)

Skills & Expertise

HPLC

cGMP

Documentation

SOP

Dissolution, UV-Vis, Karl- Fisher

GMP

Sop

Dissolution

V&V

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21 CFR Part 11

Education

Stevens Institute of Technology

Master's of Science, Pharmaceutical Manufacturing, 2008 - 2010

Stevens Institute of Technology

Master's of science, Pharmaceutical Manufacturing, 2008 - 2009

HNG University

Bachelor of Science, Pharmaceutical Sciences, 2004 - 2007

Hemchandracharya North Gujarat University

Bachelor's of Science, Pharmaceutical Science, 2004 - 2007

Activities and Societies: MEMBER OF NATIONAL SERVICE SCHEME,

POLIO VACCINATION PROGRAMME COORDINATOR

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JIGNESH SHAH

Chemist

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

Contact JIGNESH on LinkedIn

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