Manufacturing Quality Assurance

Ruchi Patel

**********@*****.*** 248-***-****)

Objective

Seeking a Quality position in the Pharmaceutical/ Bio Pharmaceutical Industry to obtain a broad knowledge of the professional world utilizing my academic knowledge, with abilities, attitude and skills of professionalism.

Education

●MS in Pharmaceutical Manufacturing, Stevens Institute of Technology, Hoboken, NJ.( Sept 2014 – May 2016)

(GPA – 3.5)

●MS in Pharmaceutics, Srinivas College of Pharmacy, India. (Sept 2011-Aug 2013) (GPA- 3.90)

●BS in Pharmacy, Srinivas College of Pharmacy, India. (Sept 2007- Aug 2011) (GPA- 3.82)

Academic Certification

●Validation and Regulatory compliance, Pharmaceutical Manufacturing Practice, GMP Training

Academic Projects

Validation of Microwave Oven including IQ, OQ and PQ, Pharmaceutical project management of the pharmaceutical company, BMR Writing of the Manufacturing of Cisapride tablet, Study on consent decree to Maquet Getinge Group, Ethical Implications of Pharmaceutical marketing to doctors, Facility design of cream and ointment facility, European new drug marketing authorization requirements, Comparison of the regulations of US FDA and Australian TGA, Manufacturing of sterile dosage form- Packaging and Labeling Department

Publications

●Thesis on “Novel Anti-psoriatic Herbal Gel Containing Cassia tora seeds extract”

●Published a research article of my thesis project in American Journal of PharmaTech Research (AJPTR)

Skills:

●Academic skills: Knowledge of cGMP, ISO, ICH, 21 CFR 11

●Technical skills: Hands on experience with UV- VIS spectrophotometer, Tablet punching machine, digital pH meter, homogenizer, magnetic stirrer, Familiar with some analytical testings such as dissolution testing, disintegration testing, viscosity testing, in-vitro diffusion studies, stability studies, Thorough knowledge of different types of chromatography techniques like GC, TLC, HPLC

●Software skills: Minitab, Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Internet browsing skills

●Lab skills: Formulation and evaluation of different pharmaceutical dosage forms like tablet, capsules, syrup, cream, ointment, gel, suppository

●Strengths: Excellent vocal and communication skills, Ample analytical and problem solving skills, Research oriented mind with thorough understanding of pharmaceutical manufacturing, six lean sigma concept, validation and regulatory requirements,Exceptional skills of organizing, planning and managing of the team projects

Work Experiences

Stevens Pharmaceutical Research Centre, Hoboken, NJ

Process development scientist/volunteer (January 2015- December 2015)

●Developed a cleaning process for commercial products

●Prepared and tested the standards during the development of cleaning process

●Validated the cleaning process for commercial products

●Conducted a GMP internal audit of the SPRC and its projects

●Performed Design of Experiments (DoE) using Minitab 16 to determine worst case scenario

●Performed risk assessment using FMEA technique, root cause analysis, OOS Investigation, CAPA

Osaka Pharmaceuticals Pvt Ltd, Baroda, India

Production Chemist (June 2013- May 2014)

●Actively participated in production of capsules and dry syrup products

●Performed profound supervision of production operators working on fully and semi-automated capsule filling machine

●Facilitated line clearance in capsule production unit before dispensing the raw materials

●Hands on experience configuring IPQA tests such as dissolution tests, calculating weight variations and content uniformity test and Reviewed and reported unit log books

●Maintained, updated and reviewed Batch Manufacturing Records according to GMP and reporting to QA department

●Ensured the sanitation of production unit environment through cleaning, disinfection and fumigation processes

●Attended team meetings and communicated with other departments of the company to attain technical information of manufacturing instrument

Atul Pharmaceuticals, India

Quality Assurance and Quality Control- Intern (November 2010-Febuary 2011)

●Assisted the team in formulation and manufacturing of tablets and capsules, Hands on experience using tablet/capsule manufacturing machines such as Tablet Punching Machine, Capsule filling machine, types of blenders, filling equipment, sealing equipment, labeling equipment, packing equipment

●Actively participated and assisted in labelling and packaging of the tablets, capsules, reconstituted dry powders and syrups

Seasonal Volunteering Work in independent pharmacy store located in Brooklyn, NY ( Dec 2014- March 2016)

●Thorough knowledge of the various pharmacy softwares like BestRx and Prime Rx and accurately prepared prescription orders for the patients

●Precisely verified prescription information and dosage and entering patients informations into the pharmacy systems

●Processing and submitting insurance claims and also answered the phone calls from the insurance firms and the health providers

●Maintained the pharmacy inventory and the prescription records and actively provided the quality services to the patients

Extracurricular activities

●Appointed as a Secretary of the Women in Pharma club (WIP) and coordinated, assisted in organizing the guest speaker seminar on “The women challenges in the Industrial World” held on Sept 23, 2015

●Organized and participated in the event of “GMP training and certification” held on Oct 21, 2015

●Vice president of the Stevens Pharmaceutical Research Center (SPRC)

●Appointed as Vice-Captain of the regional sport team in India from 2007 to 2011 during my undergraduate.

●Appointed as Class Representative during my undergraduate

●Appointed as Cultural Secretary during my undergraduate, and was responsible for organizing, planning and managing the events

●Organized, lead the team and participated while organizing the National Pharma Week during 2008 and 2009

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