Quality Assurance Engineer

Devang Patel

****, ********** ****, ***#***, Parsippany, NJ-07054

Ph: 862-***-**** Email: *************@*****.***

Objective: To seek challenging opportunity for Validation/Quality Engineer department in the Pharmaceutical

Industry.

Summary:

• Experience as QA specialist, Process Development Scientist and in pharmaceutical sales

• Master of Science in Pharmaceutical Manufacturing Engineering

• Strong problem solving skills and team player with firm work ethics

• Completed coursework and training for Lean Six Sigma

• Sound knowledge of 21CFR part 210, 211 and 11, ICH Guidelines, cGMP, CAPA, Risk Assessment,

FMEA, Root Cause Analysis, DOE, QbD

• Detailed knowledge of Microsoft Word, Excel, PowerPoint, Minitab

Experiences:

VALIDATION ENGINEER

AMNEAL PHARMACEUTICAL, PISCATWAY NJ (18th August 2014 - Current)

• Evaluate all post approval changes and conduct proper studies

• Support cGMP program including Risk Analysis, Change Control, and Standard Operating Procedure

• Assist in evaluation of failures and out of specification results and out specification results impacting

compliance with quality, safety and other design requirements

• Write, Review and approved the validation documentation for Process validation and Cleaning

validation, Process study protocols and write a complete summery report after completion of Validation

• Participate in the generation and update of the validation master plan and validation status lists

• Assist with corrective actions

• Write Master Batch Records, review and revised the SOPs

• Assist with the development of validation and commissioning documents including Master Protocol,

Final Reports, support FDA filing for changes in approved products

• Work directly with the clients, vendors, management, and technical peers to gain consensus on design,

testing and methodology

• Develop and give technical presentations

• Lead tasks and perform independent validation and or commissioning work

• Demonstrate critical thinking skills and ability to independently develop methods and specification

QUALITY ASSURANCE SPECIALIST,

GRANULATION TECHNOLOGY INC. FAIRFIELD, NJ. (July 2013- August 2014)

• Reviewed and approved manufacturing batch record and packaging batch record

• Reviewed and Revised SOP’s according to company’s program

• Checked and approved equipment cleanliness & room cleanliness being used for tablet manufacturing &

packaging department

• Swab sampling of different equipment

• Assisted during QA internal audit

• Initiated and reviewed change control

• Conducted root cause analysis for product failure, participate in response of warning letter from FDA as

well as conducted Inspection for product complaint with proper response

• Executes QA processes including batch record review, product disposition and quality issue resolution

to maintain the flow of products and documents to meet site objectives

• Maintained all paper-based and electronic files, as necessary, to support all complaint activities

• Performs weekly and monthly reconciliations, as required, for all product quality complaints received from

Drug Safety and Customer Care

• Participate in Investigation and response of customer issues, Review technical documents like user guides, data

sheets and develop, execute, and write commissioning and validation protocols reports

• Participate in Process Validation and Qualification of manufacturing equipment

• In-process inspection of various tablet parameters like appearance, weight variation, hardness, thickness,

friability, disintegration and dissolution at compression stage

• In-process inspection of various capsule parameters like appearance, weight variation, proper closing

and size of the capsule

Part Time Experience in Same Industry:

• Conducting test protocols and procedures, and product evaluation

• Reading and writing technical reports and specifications, and maintain proper records, lab notebooks

• Generated own formulas for OTC generic products and developed it in R&D department

VALIDATION ENGINEER,

SPRC lab (Stevens Institute of Technology), Hoboken, N.J (Volunteer)

• Performed DoE for the process development for dosage form manufacturing using Minitab.

• Cleaning validation – swab testing.

• Planning and carrying of different process trial in SPRC.

• Prepared and executed IQ, OQ, and PQ protocols for oven.

• Calibration of instruments.

• Conduct recovery and testing of impurity using HPLC

• Gage R&R

• Performed risk management using Fishbone diagram, FMEA

Quality Assurance Associate Intern,

Sakar Health pvt. ltd., Ahmadabad, India Jan 2012 – Feb 2013

• Participated in the review of Quality Assurance Standard Operating Procedures

• Assisted in implementing quality assurance strategies to improve quality systems

• Issued instrument logbooks and laboratory notebooks and maintain employee training files

Medical Representative,

Themis Pharmaceutical Pvt. Ltd., Anand, India Mar 2011 – Oct 2011

• Sole aim was to generate prescription from doctors on the basis of the drug/product

• Managed adequate supply to the chemist/pharmacy to fulfill the drug demand in the market

• Successfully achieved all expectation as an individual player as well as team member

• Prepared and analyzed quarterly sales reports and do the needful to uplift the sales margin

Pharmacy Technician,

Supercare Pharmacy, Markham Village, Toronto, Canada, Apr 2010 - Sep 2010

• Accurately and efficiently preparing prescription orders and maintained patient history record

• Verified prescription information and entering patient and order information into the system

Education:

• Master of Science in Pharmaceutical Manufacturing,

Stevens Institute of Technology, Hoboken, NJ - Continue Aug 2013 - Expected completion Dec 2014

Course work: Validation & Regulatory affairs in pharmaceuticals, Project Management fundamentals,

Regulation & Compliance in Pharmaceuticals, Quality in Pharmaceutical manufacturing, Lean Six

Sigma training, Design and Management of Aseptic Pharmaceutical Manufacturing Processes,

Engineering Economics & Cost Analysis, Contemporary Concept in Pharmaceutical Validation, Good

Manufacturing Practice in Pharmaceutical Facilities Design.

• Bachelor of Pharmacy,

Rajiv Gandhi University of Health and science, Karnataka, India Sep 2004- Nov 2008

Course work: Human Anatomy and Physiology, Pharmaceutics, Pharmacognosy, Pharmaceutical

Organic and Inorganic Chemistry, Physical Pharmaceutics, Pharmaceutical Microbiology and

Biotechnology, Phathophysiology, Applied Biochemistry, Medicinal Chemistry,

Pharmaceutical Engineering, Pharmacology and Toxicology, Pharmaceutical Technology and

Biopharmaceutics, Instrumental and Biomedical Analysis.

• Academic Project Work :

Building a facility for Manufacturing of Sterile product

1.

ICH Q10-Pharmaceutical

2.

OSD defects and Coating

3.

Pharmaceutical Facility Design

4.

Major Pharmaceutical Operations

5.

Stability Study in Pharmaceutical Industry

6.

* References upon request

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