BHAKTI THAKKAR

*** ********** ****, *******, ** - 10901

abu3l3@r.postjobfree.com, 201-***-****

PROFESSIONAL EXPERIENCE

TRAINING SPECIALIST since 08/2012

Novartis Pharmaceutical Corporation, Suffern, NY (Kelly Services)

W orking on NIP Remediation Project.

Performance Improvement Initiative Team Member.

Revising and Improving Granulation Procedures to reflect the current procedures.

Keeping track of Monthly Training Spot Audit.

Provide Training on Good Documentation Practices and Training and Documentation SOPs to Production

Associates.

08/2010 – 05/2012

PROCESS ENGINEER - QUALIFICATION/ VALIDATION PROJECT

Stevens Pharmaceutical Research Center, Hoboken, NJ

Prepared Raw Material and Equipment Checklist.

Prepared FMEA policy and performed FMEA of all equipment.

Prepared SOPs and Calibration Protocols, Calibrated lab instruments and maintained their calibration records in

Track-Pro.

Provided Training to other team members on SOPs of equipment.

Developed and Executed IQ and OQ protocols for Equipment and, maintained their qualification records and

reports.

Saved documents in M-Files, the Electronic Document Management System, on Project Server.

Prepared and maintained lab Notebook .

Submitted the project on time with presentation.

Provided training on SOP of Chemical Handling and Safe Working Practices in SPRC Laboratory, Spiking &

Swabbing Techniques, calibration, Verification & System Suitability of TOC Analyzer.

PROJECTS:

Implementation of Process Analytical Technology on Clean-In-Place using Total Organic Carbon Analyzer.

Pharmaceutical Cleaning Process Improvement using Design of Experiments .

Analyzed and Discussed Quality Trends observed in FDA Warning Letters to Clinical Investigators.

04/2011 – 05/2012

LIBRARY CIRCULATION DESK EMPLOYEE

Stevens Institute of Technology, Hoboken, NJ

Managed library Workflows Database to ensure records are updated.

Provided assistance to students and visitors, prepare and handled reserve items .

Troubleshoot computers and printers in the library.

Trained new students for the circulation desk services.

09/2009 – 06/2010

Quality Associate

Bennet Pharmaceuticals, Gujarat, India

Learned tablet manufacturing process including blending, granulation, drying, and compression.

Prepared process protocols and SOPs.

Prepared calibration protocols and performed calibration of lab equipment

Performed Quality Control tests for tablets.

09/2008 – 11/2008

VICE PRESIDENT FINANCIAL ASSISTANT

Bhakti Exporters Pvt. Ltd., Gujarat, India

Received Quotations, Purchase Orders, BL and, Analysis Reports.

Prepared Performa Invoices and reviewed logistic reports to ensure accuracy.

Answered business calls from buyers and vendors and responded to inquiries through e -mail.

EDUCATION

M.S. in Pharmaceutical Manufacturing, Stevens Institute of Technology, Hoboken, NJ, 2012, GPA: 3.57

Bachelor of Pharmacy, Rajiv Gandhi University of Health Sciences, Karnataka, India, 2009, GPA: 3.93

Achievements/Honors:

Certified Trainer – Novartis Pharmaceutical Corporation

Certified TOC Operator – Stevens Pharmaceutical Research Center (SPRC)

SKILLS

Software: ESOPS, LMS Space, Minitab-16, M-files, MS Office, MS Project, Mac OS

Validation: Process Validation, Cleaning Validation, Writing Protocols and Reports, Instrument Calibration,

Installation Qualification, Operational Qualification, Performance Qualification, Training Personnel, FMEA, Root

Cause Analysis, CAPA, Knowledge of various FDA regulations and ICH Guidelines

Statistical Techniques: Design of Experiments, Control Chart, Fish Bone Diagram, ANOVA, Process capability

and, Gage R & R

Laboratory: TOC Analyzer, UV Spectrophotometer, Colorimeter, Chromatography Techniques, Knowledge of

HPLC

Technical Writing: Trained on Novstyle

Relevant Course Work:

Validation & Regulatory Affairs in Pharmaceutical industry

Contemporary concepts of Validation in Pharmaceutical Industry

Good Manufacturing Practice in Pharmaceutical facilities design

Quality in Pharmaceutical manufacturing

Lean Six Sigma in Pharmaceutical industry

Bioprocess technology in API manufacturing,

Biopharmaceutical Facility Design,

Engineering economics and cost analysis, and

Project Management in Pharmaceutical Industry

Soft Skills: Excellent Writing and Communication Skills

Personality Type: ENTJ - Extrovert, Intuitive, Thinking and Judging - Myers Briggs

Conflict Dealing Style: Collaborating

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