Quality Assurance Manufacturing
Resume:
Mihir Patoliya
Email: *****.********@*****.***
Cell- 201-736-
9752
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OBJECTIVE:
To attain a respectable position in pharmaceutical or biotech industry by
contributing advanced knowledge of pharmaceutical productions, QA, QC and
validation skills.
CAREER PROFILE:
Strong analytical and solve troubleshoot and team player with firm work
ethics.
Self motivated, natural leader, with excellent organization and
communication skills.
Willing to learn new skills, hardworking, flexible.
Through knowledge of FDA, cGMP and GLP, validation, HPLC.
Expert in Microsoft project, Microsoft Visio, Microsoft office, Microsoft
Power point and excel.
WORK EXPERINECE:
Stevens Institute of Technology
Jan 2010 -
Present
Research Assistant - Stevens Institute of Technology
. Developing Cleaning Validation Study for hard to clean
product using swab sampling and TOC analyzer.
. Developing method for determining LOD (limit of Detection)/ LOQ
(limit of quantification) for the siever's 900 TOC analyzer.
. Drinking Water bottle analysis using TOC Analyzer
. Maintain Electronic records in M-Files.
. Reviewed developmental studies, SOPs,lab reports and risk
analysis documents
. Developed FMEA for design, process and equipment
. 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
. Prepared and maintained logbook according to GMP standards
Mahrshee Laboratories Pvt. Ltd, India
Chemist
Oct 2007 - July 2008
Examined and analyzed the chemical and physio-chemical properties of raw
materials, in-process materials and finished products.
Prepare reagents, samples, and standards according procedure
Document testing, observations, deviations and results.
Follows Standard Operating Procedure (SOP) under close supervision by
Supervisor.
Maintain SOP and batch record.
Performed validation studies like Analytical method validation, Cleaning
Validation, Computer System Validation and Validation of Equipment like
oven and Autoclave
Aan Pharma Pvt. Ltd., India (Intern)
Aug 2006 - Dec2006
Training in tablet, syrup, oral liquid, injection manufacturing department.
Work with Quality Assurance department.
EDUCATION:
Stevens Institute of Technology, Hoboken, New Jersey
GPA: 3.60
Major: MS in Pharmaceutical Manufacturing
Certificate:
Pharmaceutical Manufacturing Practices
Bioprocess Systems in Pharm. Mfg.
Project Engineering in Pharmaceutical Manufacturing
Relevant Coursework:
GMP in pharmaceutical manufacturing
PAT in pharmaceutical operations
Bioprocess technology in API manufacturing
Pharmaceutical finishing and packaging system in solid dosage forms
Validation and regulatory affairs in pharmaceutical industry
Rajiv Gandhi University of Health Science, Bangalore, India
GPA: 3.85
Bachelor of Pharmacy
Pharmaceutical formulation and development
Pharmaceutical engineering
Pharmaceutical biotechnology and applied biochemistry
Pharmacology
Pharmacognosy and phytochemistry
Projects:
Granulation Techniques and Validation of Granulation Process.
Robotic Processing in Barrier-Isolator Environments: A Life Cycle Cost
Approach.
Process design requirements for the biopharmaceutical facility.
Use of Six Sigma in Pharmaceutical Industry.
Skill:
. Laboratory Skill: HPLC (Schimazu), TOC (Sievers 900), Swab sampling,
TLC, Electro-chemical titrations, Chemical preparation, Pharmaceutical and
Microbiological assay, UV visible and IR spectroscopy, PH meter,,
Conductivity, Dissolution, Disintegration, Friabilator, Centrifugation.
. Interpersonal Skills: Good Communication and Writing Skill, Able to work
in team as well as individually, multitasking and problem solving skill.
ACTIVITIES:
Member of ISPE (International Society of Pharmaceutical Engineering),
Member of Pharmacy Council India, member
of culture program.
HOBBIES: Listening Music, Driving, Cricket
Contact this candidate