Quality Control Manufacturing

Nirav Patel

** ******* ***, ****** ****, NJ ***06 Contact-201-***-**** ************@*****.***

OBJECTIVE: Actively looking for full time/contract position in the pharmaceutical/biotech industry to utilize my education, experience, and skills in the field of production, validation, Quality Control /Assurance, R & D, and Laboratory.

EDUCATION: Stevens Institute of Technology, Hoboken, New Jersey

Master of Science in Pharmaceutical Manufacturing Engineering May 2012

• Introduction to Pharmaceutical Manufacturing, Good Manufacturing practice (GMP), Validation, CAPA,CIP,Process Analytical Technology (PAT) and Quality in Pharmaceutical Manufacturing, Aseptic Pharmaceutical Manufacturing Processes,pharma finishing and packaging-solid dosage manufacturing, project management, regulations and compliance, computerized validation system.

National college of Pharmacy, Karnataka, India

Bachelor in Pharmacy Sep. 2009

CERTIFICATES: Pharmaceutical Manufacturing Practices (PMP), Validation & Regulation Affairs (VRA)

SKILLS: Quality Skills: 21 CFR part 210 & 211, 21 CFR part 11

Software: M-Files 8.0, MS Word, MS Excel, MS Power Point, MS Project

Laboratory Techniques: calibration of lab instruments,HPLC, GC, TLC, UV Spectroscopy,pH,Media Preparation, Autoclave, Microbiological assays, ELISA test, Qualitative and Quantitative Analysis of chemical compound.

Regulatory skills: cGMP, FDA, ISO 13485, ISO 9000 and ICH guidelines.

EXPERIENCE:

Steven Institute of Technology, Hoboken Jan 2012-May 2012

Computer System Validation

• Created work flows for M-Files Software Validation.

• Created documents like URS, Risk Assessment, Validation Plan, and IQ, OQ, PQ protocol, User Acceptance test Protocol, Vendor Risk Assessment Checklist, and Final Validation Report.

Stevens Pharmaceutical Research Club (SPRC), Hoboken, NJ Jan 2011-Dec 2011

Validation Engineer

• Prepared Installation Qualification protocol, Operational qualification protocol, material flow, process flow, SOPs track pro calibration.

• Solved problems in team, Give suggestions for best results.

• Conductivity Development, Content uniformity, Temperature distribution, Process control and process capability, Cleaning process, cleaning limits and Data evaluations, cleaning validation sampling as per regulatory requirements.

• Worked in M-files (Electronic Document Management System), Maintain laboratory records.

• Developed and maintain reports in M-files.

• Followed SOPs and cGMP regulations.

• Schedule, organize meetings and communicate with team members.

• Followed industrial regulations

Stevens Institute of Technology, Hoboken, NJ

• cGMP training by Prof. Elaine Pratt

West Coast Pharmaceutical Works Ltd Nov 2009 – July 2010

QC Analyst

• Performed in process quality tests by analyzing tablets for dissolution, disintegration Using HPLC, GC, UV Spectroscopy, check the purity of the batch samples.

• According to cGMP regulations, SOPs reviewed and revised.

• Sampling of raw material performed.

• Inspection of blister packaging for tablet.

• Documenting the work activities done as required by Batch Record and 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.

Shalby Hospital Pharmacy (Pharmacy Technician) Sep 2009 -Oct 2009

• Took prescription orders, Dispense drug in correct dosage form and explain about drugs to patient.

• Inform patients about drug use and warnings.

National college of Pharmacy (Laboratory Technician) Nov 2008-July 2009

• Disintegration/ Dissolution testing, hardness test, blend uniformity, Friability testing, Content Uniformity, Lab Scale Manufacturing of tablet, Suppositories, ointment, cold Cream.

National College of Pharmacy (Quality Control Lab Technician) Sep 2006-August 2008

• Sampling of raw materials.

• Testing on tablet for various test like dissolution test, Disintegration test.

• Follow cGMP regulations, SOPs and other required document.

• SOPs can be review and followed.

• Use of HPLC, UV Spectroscopy as laboratory scale.

• Check the purity of batch sample

• Maintain laboratory records using document management system.

• Inspection of batch product under senior supervisor.

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