Quality Assurance Management

UTSAV AMIN

*** *** **** ***, *** # **, Union City, NJ 07087

Cell: 602-***-****

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

OBJECTIVE To obtain position that will enable me to utilize my strong

organizational skills, educational background and training

experience at research-driven Pharmaceutical organization.

EDUCATION Stevens Institute of Technology, Hoboken, NJ

Master of Science in Pharmaceutical Manufacturing

Engineering May 2010

GPA: 3.76

RELEVANT GMP Validation & Regulatory

Affairs

COURSE Regulation & Compliances Contemporary Concepts of

Validation

Project Management Quality in

Pharmaceutical Manufacturing

PROJECTS Cleaning Validation for developmental, stability and

clinical lots

Software packages for (CAPA) Corrective and Preventive Action

Management

Bio-Pharm Facility for making sterile protein product using Cell-

culture Technology

Rajiv Gandhi University of Health Science, Bangalore, India

Bachelor of Pharmacy

December 2007

GPA: 3.89

SKILLS Lab Skills: Analysis of Chemical compounds, Titrations,

Chromatography, UV Spectroscopy, Microbiological Assay,

Identification and Tests of organic and inorganic compounds

Software Skills: Microsoft Office, Microsoft Visio, MS

Project, Minitab

WORK Core Pharma, LLC Middlesex, New Jersey

January 10'- At Present

EXPERIENCE Quality Assurance & Complaint Handling System Coordinator

. Develop, apply and maintain quality requirements and standards

for development and manufacturing products & Complaint

Handling System

. Sound knowledge of Adverse Event Reporting System and FDA

MedWatch forms ( FDA 3500 )

. Investigations relating to root cause of customer complaints,

proposes and implements corrective and preventative actions as

required

. Familiar with complaint investigations, trending methods and

investigation tools.

. Works on complex investigations and coordinates technical teams

to ensure sound experimental design, effective data analysis,

identification, implementation, verification and validation of

CAPA, and subsequent closure of investigations

. Assist in the evaluation of Product Service Reports and

Vigilance.

. Sound knowledge of FDA regulations ( 21 CFR Part 820, Part 210 &

Part 211 )

. Analyze poor performance in the overall quality system,

particularly faulty design of drugs, and faulty manufacturing

processes

. IQ/OQ/PQ, Protocol Execution and Process Validation.

. Serve as the primary Quality Assurance resource to department

supervisors for problem resolution, loss reporting and

continuous improvement and Material Review Board

. Support concurrent engineering efforts by participating in

design development projects representing Quality Assurance and

the customer.

. Design and implement methods for process control, process

improvement, testing and inspection.

. Promote and execute quality standards, inspection processes,

test methodology, quality plans, documents and report to quality

system management and effective management of Quality

Documentation.

. Review change requests, deviations and CAPA documents to ensure

that the necessary criteria and provisions are included in

quality and process plans.

. Participate in internal and external quality audits and assist

in Process Certification

. Interface with quality representatives concerning problems with

quality assurance and assure that effective corrective action is

implemented.

ACTIVITIES Pharmacy Council of India (PCI), International Society of

Pharmaceutical Engineering (ISPE)

Available to Work: From June -2010

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