PRATIK PATEL

Contact: 917-***-**** Email: o2a95g@r.postjobfree.com

OBJECTIVE:

To obtain a challenging position in a well established organization where I can work enthusiastically and exploit my educational knowledge, skills and intelligence for the growth of company.

SUMMARY:

Skills acquired through academics and industrial experience

• CAPA

• Change Control

• Document Review

• TrackPro and M-Files • Qualitative and Quantitative lab methods

• Risk Assessment and FMEA

• TOC, HPLC, UV

• Minitab 16 (Statistical software)

EDUCATION:

MS in Pharmaceutical Manufacturing Engineering 05/11

Stevens Institute of Technology, Hoboken, NJ

Graduate Certificate: Validation Engineering, Regulatory Affairs

GPA: 3.59

Major Subjects:

Introduction to Pharmaceutical Manufacturing, Introduction to Project Management, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Pharmaceutical Finishing and Packaging Systems–Solid Dosage, Quality in Pharmaceutical Manufacturing, Good Manufacturing Practice in Pharma., Design/Management of Sterile Pharmaceutical Manufacturing, Contemporary Concept Pharmaceutical Validation, Engineering Economics & Cost Analysis, Regulation and compliance in Pharma.

Shri B. M. Shah College of Pharmaceutical Education and Research Institute

Bachelor of Pharmacy 05/08

GPA: 3.8

WORK EXPERINCE:

Validation Engineer, Qualification/Validation Project 08/10-12/10

Stevens Institute of Technology, Hoboken, NJ

• Performed Validation activity using Design of Experiment, Process development and control, Process Capability, Statistical development like Gage R&R and ANOVA using Minitab 16.

• Performed Cleaning Validation activities by swab sampling using TOC analyzer.

• Authored and Executed Process Validation protocols. Document for each report including deviations and IQ, OQ, PQ protocols for manufacturing equipment at lab scale.

• Developed SOPs and Master Batch Record for the project.

• Prepared the Project schedule using MS project Software.

• Responsible for review of SOPs, Spread Sheets, Batch Records, Risk Analysis Document, Lab Reports and Developmental studies.

• Provided technical and quality support for the design and validation of GMP Isolator.

• Prepared and maintained logbook according to cGMP standards.

Validation/QA Specialist, Kayvee Aeropharm Pvt. Ltd., Gujarat, India. 04/08-06/09

• Responsible for preparation of various Batch Manufacturing Record and protocols as per cGMP.

• Development, approval and execution of validation protocols. (IQ/OQ/PQ)

• Responsible for Validation of Spread sheet and Protocols.

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

• Analyze Verbal and Stastical to prepare data and reports.

• Responsible for reviewing the System Specification and requirement Documentation.

• Comply and tabulate Stastical records. Collect and analyze production data points indicative of quality of quality performance and graph performance.

• Performed project considering Six Sigma, PAT, QbD and Validation Risk Assessment in order to increase product quality and reduce validation efforts.

• Provided technical training to validation team in preparing validation protocols, executing validation projects, and interpreting test data.

• Developed FMEA, Fishbone and Process Flow Diagram for design, process and equipment.

• Participated in review/approval process of Functional Requirement Specification and Detailed Designs for “GMP Critical” equipment.

• Responsible for reviewing Batch records, COAs, CAPA document until closure.

• Responsible for execution of Site Acceptance Testing (SAT) of GMP systems and equipment.

• Co-ordinate and performed internal and external audit to ensure compliance with GMP.

• Responsible for weekly project status updates to senior management and with focus on milestone accomplishments, challenges and status of project schedules.

Quality Control Analyst, United Industries, Gujarat, India 04/07-03/08

• Analysis and Evolution of in-process samples and finished product samples. (pH, conductivity, % ash)

• Responsible for performing analytical test using Spectrographic methods like HPLC, UV and TLC to ensure the quality of the product.

• Water analysis of process water, drinking water including waste water analysis. (COD analysis)

• Preparation and Standardization of laboratory reagents and analytical solution.

• Calibration of laboratory equipment such as pH meter, Conductivity meter, Karl Fisher Moisture Titrator.

• Responsible for line checking of release parameters such as physical checks i.e. leak, net contents, coding and appearance.

• Analyzing the % moisture content of finished goods and coordinating with the control operator for necessary adjustment of moisture content.

• Responsible for Development and execution of lab reports, batch records and SOPs.

• Responsible for weekly project status update to the senior management.

ACADEMIC PROJECTS:

Presentation:

• “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.

• Presented project on “Process Robustness”.

• “Design of Tablet Manufacturing Facility”, step by step design of each unit operation facility in tablet manufacturing.

• Computer System Validation, including Part11.

• Commissioning / Qualification.

• Failure Mode and Effect Analysis (FEMA) Principles

• Lyophilization Process, Validation Practices.

• Management Clean Construction / Clean Room Design / Validation.

• Design/Management of Sterile Pharmaceutical Manufacturing.

• Validation and Regulatory affairs in Pharmaceutical Manufacturing.

SKILLS:

• Lab Skills: Proficient in qualitative and quantitative lab methods, Formulation and evaluation of pharmaceutical products, dissolution, Disintegration and diffusion apparatus, Swab sampling, TOC, Coupon studies, HPLC, UV, GC.

• Computer Skills: MS office, Windows XP/Vista/7, Minitab 15 and 16, TrackPro, M-files and the internet.

• Interpersonal Skills: Good communication and writing skill, able to work in a team as well as individually, multitasking and problem solving skill.

REFERENCE: Available upon request.

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