Quality Control Manufacturing
Resume:
JYOTI AGRAWAL
Edison, NJ ****7
acy40i@r.postjobfree.com
Objective: To work as a Quality Control Executive in a Pharmaceutical manufacturing company and grow professionally using my excellent analytical skills
Academics:
Bachelor of pharmacy from Shri G S Institute of Technology and science, Indore, Affiliated to Rajeev Gandhi Proudyogiki Vishwavidhayalay, Bhopal (M.P.)
Diploma in Pharmacy from Devi Ahilya college of pharmacy, Indore, Affiliated to Rajeev Gandhi Proudyogiki Vishwavidhayalay, Bhopal (M.P.)
Summary:
More than 6 years of industrial Quality Control experience in Ranbaxy Laboratories Ltd (India) and Appco Pharma (USA).
Well versed in all modern instrumentation such as HPLC, GC, AA, UV, IR, etc., as well as various other analytical techniques and calibration of these instruments
Excellent analytical skills and extensive experience in Analysis of different dosage formulation
Familiar with various manufacturing processes used in Medicine Manufacturing Plant, process and cleaning validation, documentation system, SOP’s, cGMP, GLP, and cGCP
Familiarity with NDA/ANDA (CMC Section) preparations and reviews and FDA regulations.
Exposure of MHRA, TGA, ENVISA and USFDA Audit.
Successfully implemented numerous targeted & effective analytical procedures for different Products
Experience in various dosage forms such as tablets, capsules and dry syrup.
Experience in bulk and finished product analysis.
Well versed in generation, maintenance and revision of SOPs, specifications, procedures, training, OOS investigations, and other documentation systems.
Wide exposure to quality control, quality assurance, manufacturing, validation, compliance and regulatory areas in a pharmaceutical manufacturing environment.
Excellent interpersonal, communication, managerial and organization skills.
Proficient with common computer software.
Awarded by “Global Appreciation Award” and “SPOT Award”(Outstanding Performance Award) in the month of April 2010.
Worked as departmental training coordinator.
Collected data to do reduce testing of drugs.
Experience:
Appco Pharma, Somerset, NJ Nov-2016 to Present Appco Pharma is generic Pharmaceutical Company. The generic drug portfolio consists of numerous products across a wide range of therapeutic areas.
Roles and Responsibilities:
Analysis of stability batches and commercial batches
Analysis and testing of Raw material
Documentation of data with regulatory compliance and for audit preparation.
Maintaining GLP and GMP compliance in working area.
Following SOPs and STPS for doing analysis of product.
Ranbaxy Laboratories Ltd., Dewas, India May-2006 to Sept-2012
Ranbaxy Laboratories Ltd. is a research based International Pharmaceutical company. Ranbaxy is a member of the Daiichi Sankyo Group. Daiichi Sankyo is a leading global pharmaceutical innovator, headquartered in Tokyo, Japan. In India, Ranbaxy lab has manufacturing and Quality Control plants for drugs (Tablets, Capsules, Dry Syrup, Injections) at multiple locations.
Roles and Responsibilities:
Analysis of in-process and finished product.
Documentation of data with regulatory compliance and for audit preparation.
Maintaining GLP and GMP compliance in working area.
Following SOPs and STPS for doing analysis of product.
Maintaining proper records of training and qualification of analyst
Provide training to supervisors for maintaining GLP and GMP compliances.
Quality Control Tools and Technology:
HPLC (High Performance Liquid Chromatography), GC (Gas Chromatography), IR and UV Spectrometer, Melting point Apparatus, Refractometer, Viscometer, pH Meter, Titrations, Karl-Fischer Titrator, Potentiometric Titrator
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