Sumit Patel

*** ***** ****'s avenue, Jersey city, NJ-07306

abmct9@r.postjobfree.com

Summary:

. Excellent experience as a Quality Engineer.

. Experience in CMC and Regulatory affairs group in development and

maintenance of Quality Standards.

. Highly knowledgeable in DoE (Design of Experiment), data interpretation,

FMEA, CAPA, risk based approach, 5why and cleaning validation.

. Good in document management and compliance.

. Good in testing of raw material, In-line process material and final

product.

. Good skill in performing quality testing, maintaining both paper &

electronic record.

. Authoring, writing and reviewing new products.

. Ability to perform in NDA, INDA & ANDA application.

. Knowledge of CIP, SIP, HVAC and WFI protocol and process.

. Swab sample analysis by TOC analyzer for cleaning Validation.

. Good knowledge in HPLC and uHPLC

. Responsible for documentation management.

. Good in document management systems such as DBO/ MIDAS/ QSIS/ QSAS/ M-

Files/ FDB/ Whereused Systems.

. Regulatory information management, Document management contains Record

Management, Documentation, Master document management, Version

Maintenance.

Skills:

Technical / Software Skills: Minitab 16, DBO, MIDAS, QSAS, QSIS, CoreWMA MS

Word, MS Excel, MS Power-point, MS Project.

Quality: Exceptional knowledge of cGMP, GLP, GCP, QSR & ICH

quality guidelines.

Validation & Regulation: Academic concentration on Validation &

regulation for pharmaceuticals, and knowledge of

P&ID, IQ, OQ, PQ, VMP, SOP.

Education/ Certification:

. Validation & Regulation Professional Certificate

. Pharmaceutical Manufacturing Practice certificate

. M.S in Pharmaceutical Manufacturing from Stevens Institute of Technology,

Hoboken, NJ, 2011

Major: Validation, Quality & Regulation

. B. pharmacy from N.G.S.M. Institute of Pharmaceutical Sciences,

Mangalore, India,

Major: Pharmacy.

Courses: Pharm. Organic, Inorganic and analytical Chemistry, Medicinal

Chemistry, Microbiology, Bio-Pharmaceutics, Clinical Pharmacy,

Pharmacology & Pharm. Engineering

Experience:

Merck & Co, Inc., Summit, NJ

Oct 11 - Present

QS Consolidation Specialist / Regulatory Scientist

(CMC & Regulatory Affairs group-Quality Standards)

Responsibilities:

. Authoring, writing and reviewing new products.

. Changes / updates with regards to post approval compliance.

. Keep track record of product life cycle in Global Change Management

system.

. Responsible for providing compliance supports to all global sites.

. Verify impact assessment of updated product (with cooperation of global

sites and global regulatory agencies).

. Experience in CMC and Regulatory affairs group in development and

maintenance of Quality Standards.

. Routine communication with international stakeholders and within

department to finalize specification and methods.

. Responsible for documentation management.

. Good in authoring of all type of analytical methods.

. Responsible for review/ update/ author/ publication of test methods in

accordance with client policies, guidelines and procedures.

. Daily communication with management for support and issues discussion.

. Resposible for review and approval of regulatory compliance issues.

. Experience in filling change control and reviewing change control in

Trackwise system.

. Working understanding of the pharmacopoeia (USP, PhEur, JP etc.).

Novel Labs, Somerset, NJ

Sep 11 - Oct 11

Analytical Research and Scientist

Responsibilities:

. Conduct instrumental analysis for release and stability testing of

developmental and commercial API and drug products in support of

clinical testing for IND and commercial NDA submissions.

. Performs independent laboratory analysis and assists in ensuring

smooth laboratory operations.

. Method transfers, method validation and analyses of late-stage

developmental compounds and finished products in support of clinical

testing for regulatory submissions.

. Conducts routine testing using compendial and validated methods for a

variety of analytical techniques including, but not limited to HPLC,

Dissolution, Karl Fischer, UV/Vis, TLC, and other analytical lab and

instrumental testing.

. Independently executes documents and draws conclusions from

experiments for laboratory investigations as well as independently

conducting and authoring investigations that are clear, concise,

identifies the appropriate root cause and conclusion.

. Documents raw data according to GDP's and cGMP's from analysis and

has expert knowledge with data retrieval and input to/from databases.

Stevens Institute Research Center

Jan 11 - May 11

Quality Engineer:

. Prepared Quality manual, Quality Policy of project.

. Design of process based on six sigma.

. Verification of Equipment.

. Preparation and implementation of training program.

. Management of document life cycle.

. Preparation of standard operating procedures (SOP)

. Review and approval of documentation.

. 21CFR 210, 211 and Part 11 compliance.

. Preparation of CU spreadsheet.

. Preparation of Quality Audit manual.

. cGMP Documentation.

Stevens Institute Research Center

Sep 09 - Dec 10

Validation Engineer:

. Developed IQ, OQ and PQ procedure for equipment.

. Visual coupon inspection.

. Validation of equipments

. Prepared Validation Master Plan for project (VMP).

. Prepared Cleaning Validation method by use of DoE experiment.

. Prepared Protocol of Process Validation & Cleaning Validation.

. Validate CU Spreadsheet.

. Performed CAPA and FMEA of the equipment and process.

Micron Pharmaceutical Ltd., Vapi, India

Jan 08 - Jun 09

Quality Control Associate

Responsibilities:

. Strong work experience in QC (in-process) department to maintain the

quality, purity & efficacy of the product.

. Good analytical knowledge coupled with problem solving skill.

. Performed quality test on raw material, In-process material and the final

product to check, evaluate the area of problem in the process.

Some of the tasks are as follow:

. Calibration of Basic Lab Instrument.

. Preparation of Stock, Test and Standard solutions.

. Performed Stability studies on the finished product.

. Maintained Lab records, Instrument log-book and note-book as per GMP

documentation requirement.

. Tracked samples and chemicals using LIMS.

. Analyzed API by use of HPLC.

. Performed Testing of finished product using HPLC and Ion-Exchange

chromatography.

. Performed viscosity testing, stability testing, dissolution and

disintegration testing, hardness testing, friability testing and content

uniformity and blend uniformity testing.

. Use of caliper, micrometer, gage etc.

. Performed Certificate of Analysis on pharmaceutical material.

Members:

. ASQ: Member of American Society for Quality.

. RAPS: Active member of Regulatory Affairs Profession Society.

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