Project Six Sigma

PARESH PATEL ** Liberty Ave,

201-***-**** Jersey City,

**********@*****.*** NJ - 07306

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OBJECTIVE:

Seeking full time or contract position in the field of Pharmaceutical Industry.

EDUCATION:

M.S in Pharmaceutical Manufacturing May 2012

Stevens institute of Technology, Hoboken. GPA: 3.47

Bachelor of Pharmacy Sep 2009

Rajiv Gandhi University of Health Science (RGUHS), Bangalore, India GPA: 3.77

EXPERIENCE:

Stevens Pharmaceutical Research Center-SPRC (Hoboken, NJ) (Academic Project) Aug 2011 – Dec 2011

Validation Engineer

•Project was based on launching of new product in market

•Prepared Validation master plan for initiating project.

•Advised team members on various improvement areas of the process.

•Conducted test Protocols includes Installation qualification, Operational qualification & Performance qualification.

•Prepared Process Validation & Cleaning validation protocols and reported it.

•Made appropriate adjustments to equipment and process as per specifications

Computer System Validation (Academic Project) Jan 2012 – May 2012

(Project- Validation of Electronic document management system, M-Files 8.0)

• Created Workflows for the validation of M-Files 8.0

• Created documents like URS, Risk Assessment, Validation Plan, Vendor risk assessment check list, IQ Protocol, OQ Protocol, PQ Protocol, User acceptance test protocol and Final validation report.

Rise Remedies Ltd. (Baroda, INDIA) Nov 2009 – July 2010

QC Analyst

•Performed process quality tests by analyzing tablets for dissolution and disintegration

•Checked the purity of batch samples using HPLC, GC, and UV Spectroscopy.

•Responsible for coordinating necessary research to determine root cause and corrective/preventive actions.

•Reviewed and Revised SOPs according to cGMP regulations.

•Performed sampling and reconciliation of raw materials.

•Inspection of blister packaging for tablet.

•Documented the work activities done as required by Batch Record and/ or SOPs.

•Performed sampling and inspection functions for raw materials and packaging components.

•Reviewed the documents such as batch records, log sheets for verifying the activities that has been performed.

Pharmacist at VRAJ PHARMACY (Baroda, INDIA) Sep 2009 – Nov 2009

Pharmacy Technician

•Took prescription orders

•Dispensed drugs in correct dosage form and explained about the drugs to the patient.

•Informed patients about drug usage and warnings.

Rise Remedies Ltd. (Baroda, INDIA) Apr 2008 – Nov 2008

•Participated in training on quality control, production and packaging of Liquid Oral Dosage for the department.

Stevens Institute of Technology, Hoboken, NJ Sep 2011 – May 2012 Student manager at Receiving Department

SKILLS:

•Validation skills: Validation Protocol and Reports (IQ, OQ, PQ, SDLC), Cleaning Validation, PAT, Calibration Protocol and Report Writing Risk Management tools (FMEA, FTA, Fishbone Chart), Computer system validation, Equipment Validation.

•Manufacturing skills: Process Simulation and Optimization, Design of Experiments, Quality by Design (QbD), FMEA, Six Sigma and Statistical Process Control (SPC) Tools (Histogram, Pareto Charts, Control Charts, Cause and Effect Analysis), experience with single station tablet press machine and standard coating pan in manufacturing tablets

•Analytical skills: UV/Visible spectrophotometer, HPLC, Paper chromatography, Thin Layer Chromatography & PH Meter, CIP, SIP

•Quality Skills: 21 CFR Part 210 & 211, 21 CFR Part 11, 21 CFR Part 820, CAPA, Lean six sigma (Kaizen, 5S, Process Mapping)

•Software skills: M-files, Minitab, TrackPro, Microsoft Office- package, MS project, Adobe Acrobat, Adobe Photoshop, Picasa.

CERTIFICATION/LICENSE:

•Pharmaceutical Manufacturing Practices (PMP).

•Validation and Regulatory Affairs (VRA).

LEADERSHIP:

•President of Indian graduate Student association, Stevens Institute of technology, Hoboken (Aug 2011 - May 2012)

•Excellent analytical, communication skills and ‘hands-on’ problem solving ability. Have conducted many symposiums during my Undergrad.

•Won many Dance competitions.

Contact this candidate