Six Sigma Quality

Rupen Shah

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

Jersey City, New Jersey - 07306.

Contact no.: 201-***-****

Email: ************@*****.***

SUMMARY:- To obtain challenging position in the Field of Pharmaceutical/ Biopharmaceutical industry that provides an opportunity for acquiring skills and developing existing skills.

Sound knowledge of Quality Management and Process risk based elements such as Design of Experiments, QbD, Corrective and Preventive Action system, Statistical Process Control using tools such as Histogram, Pareto Chats, Control charts, Ishikawa diagram, Failure Mode and Effect Analysis, Hazard and Operatability Analysis, Fault Tree Analysis, Triz and Value stream mapping.

Specialization in analytical method development, process validation and validation, Cleaning Validation, equipment Calibration and Qualification, Protocol development and execution, computer system validation

Quick learner and well rounded in many functions and aspects of FDA regulated environment

Experience with development of IQ, OQ, PQ, Validation Protocol and its execution.

Familiar with Commissioning, URS, FAT, SAT, VAT and RTM.

Expert in Technical documentation writing, SOPs, Validation Protocol, VMP and Reports.

Sound knowledge of aspects of lean and six sigma.

WORK EXPERIENCES:

Research Assistant- Stevens Pharmaceutical Research Center 08/2010- 06/2012

• Cleaning validation projects, Automation of GMP activities

CIP System integration with TOC Analyzer using its Turbo mode-PAT Application

• Solvent Interference Study Using Total Organic Carbon Analyzer

Studied various effects of solvent using total organic carbon analyzer and interpretation of its data, presented data during poster presentation at Stevens Institute of technology.

• Method development and validation of recovery of water insoluble compound (Theo bromine) using Total Organic Carbon analyzer

TOC analyzer is usually used to analyze water soluble compound residues. The aim of this project was to analyze residues of water insoluble compound.

• Qualification/Validation Project:

Role: Validation Engineer

Improve current formula and process using lean six sigma

Using statistical tools and quality tools like DoE(Design of Experiment), Process Capability, ANNOVA, t-test, Accuracy and Precision, Process control plan, change control, Gage Bias- linearity study and Gage R&R using Minitab16 statistical software

Performed project considering PAT, QbD and Six sigma concepts to reduce validation effort and increase product quality

Using DOE method to develop process and performed monte-carlo simulation to produce robustness.

Develop and Review SOPs, VMP, lab reports and risk analysis documents

Developed FMEA, Cause and effect diagram for design, process, equipment and Risk analysis

Authored and Executed IQ, OQ and PQ protocols for manufacturing equipments at lab scale and Process Validation protocol and documentation of each report including deviations

Validated different equipment like Autoclave, Oven, mixer.

Prepared and maintained logbook according to GMP standards

Prepared SOP and Validate Spreadsheet for the Content Uniformity

Developed and Validate swab sampling method using TOC analyzer for cleaning validation.

Using HPLC analyzer to find out Theo bromine content.

Rucha Pharmaceuticals, Ahmadabad, Gujarat, India. 04/2009- 06/2010

Production Department, Tablet and Liquid Oral section.

1. involved in various steps like dispensing, compression, granulation, coating etc.

2. Performed Quality Control Testing according to procedure

3. Checking packaging tablet

4. find out risk and solve problem

5. check quality of product and improve process development step

EDUCATION:

• Master of Science in Pharmaceutical Manufacturing Practice with 3.5 GPA

Stevens Institute of Technology, Hoboken, NJ (Oct 2010 - May2012)

Graduate Certificate: - Validation and Regulatory Affairs, Bioprocess system in Pharmaceutical Manufacturing, Pharmaceutical Manufacturing Practices, TOC Analyst

Course Work: Quality System Management in Pharmaceutical Manufacturing, Good Manufacturing Practice in Pharmaceutical Facility Design, Validation & Regulatory Affairs in Pharmaceutical Industry, Bioprocess Technology (Purification, Fermentation) in API Manufacturing, Contemporary Concepts of Pharmaceutical Validation, Pharmaceutical Finishing and Packaging system, Regulation and Compliance in Pharmaceutical Industry, Introduction to Project Management, Design and Management of Aseptic Pharm. Mfg. Processes.

• Bachelor of Pharmacy with 3.92 GPA

Rajiv Gandhi University of Health Science, Karnataka, India (Oct- 2009)

SKILLS:

Personal Skills:

Thorough understanding of cGMP, GLP, FDA, QSR, ISO, CFR, GCP requirements and ICH guidelines.

Knowledge of bioprocess technology, aseptic filling, sterile manufacturing and clean room environment.

Lab Skills: TOC Analyzer, HPLC column chromatography, tablets punching machine, dissolution & disintegration testing, Kaye validator, lab notebook, Swabbing and Spiking

Software: Minitab (Statistical Process Control), M-Files (Electronic Document Management System), MS Project, MS Excel, MS Word, Visio

Cleaning Validation: TOC analysis, Swab Sampling, Clean-In-Place, SIP, HPLC

Quality Tools: Lean Manufacturing, Documentation, Process capability, CAPA, Audit, FMEA, Root Cause Analysis, Pareto Charts, Histogram, Cause and effect analysis, 5S Concept, Process Mapping, Various tools like Poke yoke, Kaizen, various Quality GURUS method like Juran, Deming’s method.

Interpersonal Skills: SOFT SKILL (MYERS- BRIGGS and THOMAS – KILMAN TEST)

Good Communication and Writing Skill, Flexibility, Able to work in team as well as individually, multitasking and problem solving skill. My Personality Type is ENFJ and ESTJ.

Language: English, Hindi, Gujarati

AFFILIATION: - Member of ISPE

EXTRACURRICULAR ACTIVITIES:

1. Stevens Pharmaceutical Research Center

• Treasurer April 2011- May 2012

Budget planning and approval

2. Registered Pharmacist of India and Member of Gujarat State Pharmacy Council.

3. Worked projects in Stevens Pharmaceutical Research Center, Hoboken, USA

4. Participate in ISPE poster presentation competitions, 2012 NJ, USA

REFERENCES: Available upon request.

Available to Work: JUNE 2012 (Immediately available)

Available to relocate anywhere

Contact this candidate