Manufacturing Quality

Niyati Patel

*** ******* ******, **********, ** *3103

Contact: 603-***-**** Email: ******@*****.***

Summary:

•3+ years of experience in medical device and pharmaceutical industry

•cGxP (cGLP, cGMP, cGDP),

•Change Control and CAPA

•FDA 21 CFR 210,211, 810, 820(QSR)

•Risk Assessment and FMEA TOC, HPLC, UV- Analytical Methods

•Minitab 16,17 (Statistical software)/ Statistical analysis

•Lean manufacturing tools

•Theoretical knowledge of qualification and validation concept

Education:

Master of Science in Pharmaceutical Manufacturing

Stevens Institute of Technology, Hoboken, NJ GPA: 3.8 May 2016

•Quality in Pharmaceutical Manufacturing

•Good Manufacturing Practice in Pharmaceutical Facility Design

•Validation and Regulatory Affairs

•Project Management application in pharmaceutical project

•Concept of Lean six sigma

•Manufacturing of oral and sterile dosage forms.

•Intro to statistical analysis

•Validation of computerized systems

Graduate Certificates:

•Pharmaceutical Manufacturing Practices

•Validation and regulatory affairs

Bachelor of pharmacy

Gujarat University, Ahmedabad, INDIA GPA: 3.7 June 2010

Research Projects:

•Medtronic consent decree

•Japanese medical device submission requirement

•Prepared process validation report for oral solid dosage form

•Temperature mapping

•Report on DQ, IQ, OQ and PQ in pharmaceutical industry.

•Quality analysis of lyophilization of sterile products

•Prepared master production report for oral solid dosage form

•DOE (design of experiments), process

Experience:

Graduate Assistent, Registrar’s Office

Stevens Institute of Technology, Hoboken, NJ February 2015 - May 2016

•Manage record of all students using SIS (Student information system)

•Record keeping for all the controlled documents of students.

•Prepared SOPs for how to collect information from Stevens online portal.

Secretary of Stevens pharmaceutical research center

Stevens Institute of technology, Hoboken, NJ February 2015 - May 2016

•Arranged FDA guest speaker session with other pharmaceutical clubs.

•Arranged Instrument learning classes such as HPLC and TOC analyzer.

•Updated and maintained all protocols and SOPs in the SPRC laboratory.

•Performed manufacturing of oral solid dosage form and in process testing of the batch with the team.

•Performed root cause analysis.

•Prepared SOPs, URS (user requirement specification), validation master plan and validation protocols for project.

Intern (Process development and validation)

Pharma Clean Group, Hillsborough, NJ May 2015 - August 2015

•Developed and validated the cleaning validation processes for OTC products.

•Performed design of experiment(DOE) and statistical process control studies as a part of process development, improvement, simulation to get results according to specification - Process capability, Gage R&R, ANOVA and control charts using Minitab 17.

•Co-ordinate in development of CIP cycle for products.

•Performed spray ball study for the vessel in determining the spray pattern and coverage for spray ball device.

•Investigated any deviation and report it to manager.

•Performed and evaluated temperature mapping studies using Kaye validador(GE).

•Performed daily calibration of lab equipment.

Kitting associate(quality and manufacturing)

Symmetry Medical, Manchester, NH April 2011 - December 2014

•Document review of manufacturing record before shipping.

•Assisted in change control, CAPA and NCMR document preparation form inventory department.

•Maintained packaging inventory for production using MES system.

•Prioritized and managed day to day shipping schedules.

•Responsible for providing daily reports to the managers.

•Performed Lean activities around final doc control area which increase efficiency by 25%.

•Tools used are 5S, quality charts, Fishbone diagrams, FMEA, flow diagrams for kaizen and lean projects by participating in cross functional teams.

Intern (analytical R&D and quality) May 2009 - July 2009

Vital Pharmaceuticals, Anand, Gujarat, INDIA May 2010 - July 2010

•Performed in process quality checks for solid dosage form such as dissolution, disintegration, friability, hardness, assay.

•Document control.

•Participated in team lean exercises for manufacturing.

•Working knowledge of laboratory instruments such as PH meter, viscometer, friability tester, dissolution apparatus, mechanical particle size analyzer.

•Participated in validation of analytical instrument and equipment.

•Basic knowledge of LIMS (laboratory Information Management System).

Skills:

•Technical skills: Qualitative and quantitative lab methods, formulation and evaluation of pharmaceutical product, swab sampling, TOC methods, coupon studies, HPLC, UV. FDA regulation on 21 CFR, ICH guidelines, ASTM quality standards, cleaning validation, equipment validation and sterilization validation, MS office tools, MS project, MS Visio, Minitab, Lean manufacturing tools.

•Interpersonal skills: Detail oriented, multitasking, leadership, written and verbal communication and problem solving.

Professional Affiliations:

•Member of American society for Quality (ASQ)

•Stevens Alumni Pharmaceutical Club, and Stevens ISPE Chapter

Reference: Available upon request

Contact this candidate