VIVEK PATEL

** ******* ***,

Jersey City, NJ ****6

551-***-****

acw038@r.postjobfree.com

OBJECTIVE: To secure a responsible position in a field of validation and quality assurance in the pharmaceutical industry where I get an opportunity to utilize educational background and relevant experience to contribute your organization’s growth and objectives in an environment highly regulated by FDA.

SKILLS:

Lab Skills: FMEA, Fault-tree analysis, Familiar with Formulation and Evaluation of Various Dosage Forms, Cleaning Validation, Calibration of Equipment, Swab Sampling.

Instrumental Skills: Sterile ovens, Rotary vial washer, Trayloader,, Sterilizing ovens, HPLC (basic),UV-Visible Spectrophotometer, Bandelin Probe Sonicator, Brookfield Viscometer, Heydolph Rotary Flask Evaporator, USP Dissolution Testing Apparatus, Multi Station Tablet Compression Machine, karl fisher, Dissolution etc.

Software Skills: Minitab, Microsoft Office, Windows. Lab solution, class VP, M POWER.

Interpersonal Skills: Leadership, Team player, Excellent Communication, Active Listener, Results and Ethics oriented.

EDUCATION: Stevens Institute of Technology, Hoboken, NJ January 2015

Master of Science in Pharmaceutical Manufacturing

Relevant Coursework: Introduction to Pharmaceutical Manufacturing, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, GMP in Pharmaceutical Facility Design, Introduction to Project Management, Engineering Economics & Cost Analysis, Quality in Pharmaceutical Manufacturing, Manufacturing & Packaging in Pharmaceutical OSD Products, Applied Statistics in Pharmaceutical Manufacturing. This special certificate course is focused on the application of statistics and statistical software (Minitab) in pharmaceutical manufacturing, particularly in production, Quality Assurance, Quality Control, validation and analytical laboratories.

The Babaria Institute of Pharmacy, Vadodara (Gujrat), India October 2014

Bachelor of Pharmacy

CERTIFICATION:

1. Graduate Certificate in Validation, Compliance and Quality in Pharmaceutical Industry (VCQ).

Focused on compliance to various FDA regulations including cGMP and various parts of 21 CFR including main focus on Part 11,210,211, Study of ICH guidelines, Revised Process Validation guideline issued by FDA, Highlights of federal regulations of Canada, UK, India, Australia.

2. Graduate Certificate in Pharmaceutical Manufacturing (PM).

Focused on introductory overview of the industry, touching on all basic manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the industry.

EXPERIENCE:

Invatech pharma, New Brunswick, NJ, USA December 2015 to present

QA / Validation Specialist

•Responsible for execution of validation protocols. (IQ/OQ/PQ)

•Drafted User Requirements and Design Qualification templates for GMP critical systems.

• Provided guidance and statistical evaluation to interpret analytical data associated with product release, stability reports, validation activities, laboratory investigations and manufacturing investigations to support release and compliance decisions.

•Developed Fishbone and Process Flow Diagram for process and equipment.

•Co-ordinate in reviewing Batch records, COAs, CAPA document until closure.

•Development of Annual Product Reports (APR) in a timely matter and in compliance with regulatory requirements for contents, trends, and approvals.

•Assisted in writing summary reports, developing the sampling team schedule in order to provide continuous support to project.

•Helped in Defines, identifies and applies product and process control methods such as developing control plans and identifying critical control points for sampling.

•Worked as a Sampling team lead and perform all the activities related to sampling, provided training to the new employee and operators and daily updates to the Project Manager and SME.

•Perform cleaning validation/verification studies using rinse method, swab sampling and visual inspection method for the parts washer and vessels.

•Prepared various SOPs and maintain daily spread sheet for updating the results of the cleaning verification studies. Assisted in writing the cleaning verification/validation protocols for vessels and parts washer system.

• Performed cleaning validation using rinse method, swab sampling and visual inspection method.

•Co-ordinate in development of the CIP cycle for cleaning of new products.

•Temperature mapping: k-validator, disaster study, execution of the protocol, k validator pre and post calibration, uniformity testing, dynamic testing, loaded versus empty chamber study.

•Assisted with and conduct investigations, including determination of root cause, identification of corrective and preventive actions (CAPA) and establishing/measuring CAPA effectiveness. This assistance is for all company investigations with emphasis on:

Manufacturing/Packaging investigations

Laboratory investigations

Validation investigations

Stevens Institute of Technology, Hoboken, NJ May 2015 to December 2015

Student Research Intern

•Annual product review development from the data that is generated on manual basis and presented to the committee (most appreciated project)

•“A risk based approach in Cleaning Validation using Visible Residual Limits”, FDA considerations for cleaning validation”.

•“Cleaning Validation for Developmental, Stability and Clinical lots”, research various cleaning process, developed BMR and VMP for cleaning validation.

•“Success in Quality approach using ICH Q9 guideline”, using Quality Risk Management.

•“Success in Quality approach using ICH Q7 guideline”, Lean Six Sigma based on DMAIC methodology.

•“Management Clean Construction / Clean Room Design / Validation”.

•“Validation and Regulatory affairs in Pharmaceutical Manufacturing”.

•Checked Antimicrobial activity of Niosomal gel by Microbiological method.

United Industries, Vadodara (Gujarat), India December 2013 to January 2015

Manufacturing QA specialist

•Acts as a QA representative on project teams to define critical points and classify product defects.

•Responsible for ensuring cleaning, processes, equipment, and computer systems remain in a validated state. Executes periodic monitoring.

•Assisted in Review and approve validation reports in support of product release. Investigate protocol discrepancies.

•Reviewed and approved controlled documents relating to processes, cleaning, equipment, and computer systems in the manufacture of product.

•Reviewed and approved changes requests, ensuring they will not lead to breach of GMPs.

•Performed in-process bulk product sampling as well as finished goods sampling for submission to laboratory services to analysis

•Responsible person to Ensure all deviations, investigations, product dispositions, etc. are documented thoroughly and effectively

•Manage document/record control to include:

•Standard Operating Procedures

•Processing and packaging batch records, labels, inserts, and other printed materials

•Study protocols

ACTIVITIES: Member of ISPE and SPRCC.

HOBBIES: Cricket, Tennis, Travelling, Music and Cooking.

REFERENCES: Available upon request

Available to work from September, 2016

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