BHAVESH PATEL 535 Alabama Avenue, Ronald McDonald House Memphis TN USA 38105E-mail: bhavla83@gmail.comPhone No: +1-571-338-8246

Career Profile● Five years of experience in quality assurance, quality control and as a Research Associate in Analytical

Method Development in chromatographic HPLC based research.● Demonstrated ability to sort out QMS issues and collaborate with diverse cross functional teams.● Diverse auditing experience including TGA Australia, USFDA, MHRA, WHO Geneva, ENVISA.● Preparation and highlighting controls limit for specific products based on statistical tools and annual

product review (Product Quality Review).● Preparation of annual training calendar, ensuring GMP and GLP training to manufacturing and laboratory.

Expertise● Leadership

● Fostered continuing process improvement.● Demonstrated ability to lead in challenging times.

● People management● Managed a group of 4 QA/QC Specialists.● Managed difficult performance situations with appropriate remediation.

WORK EXPERIENCE:QA/QC Assistant Manager, Ideal Cures Pvt Ltd Jun 2014 - July 2016● Preparation of SOP’s and specifications in coordination with the QA Manager.● Assisting during customer audits.● Handling the internal plant audits and validation with the current GMP requirements, 21 CFR

regulations/ USFDA regulation, European Directives regulations and the schedule M.● QC testing / analysis as per the specifications as mentioned in the pharmacopeia and in-house

specifications.

CQA Annual Product Review and Training Coordinator, Claris Lifesciences Ltd Jan 2013 – Jun 2014● Preparation, review and submission of annual product review (PQR) as per the regulatory market

(USFDA, MHRA, TGA Australia and India), container wise (bottle, vial, ampules and glass bottle) to partner and annual reporting for USFDA approved product to agent of the agencies with the regulatory affair department.

● Updated changes taking place in the industry and ensure the practices are followed in the impacted department.

● Ensure that every employee gets refresher training on ICH Q7A guidelines as per training annual plan.● Rectify and impart training on QMS related issues impacted department (staff & worker) by

selecting trainers.● Maintain all records as per requirement of regulatory.

QC Specialist, Famy Care Ltd Jan 2012 - Dec 2012● Quantitation of routine drug analysis related to Stability testing protocols depending on the

conditions and stages of the stability protocol and ICH guidelines.● Withdrawal of samples, recreation and stability trends.● Dissolution and Assay testing in HPLC based method and reviewing analytical reporting based on

trends in-house defined trends (out of trend).

Research Associate, Indian Veterinary Research Institute May 2010 – Jan 2012● Research the “Monitoring of extraneous chemical substances and their residues on the animal

products” sponsored by the “Indian Veterinary Research Institute Izatnagar-Bareilly”, ICAR, MFPI & APEDA.

● Method development and validation of drug residues in different matrices in tissue, blood, and plasma by adopting the international guidelines like Codex, ICH guidelines.

Master in Pharmaceutical chemistry Final Year Project● Research/dissertation for the M. Pharm conducted on the “Method development and validation of

TOPIRAMATE by HPLC-PDA” with following the ICH guidelines. Sponsored by the “Indian Pharmacopeia Commission Rajnagar-Ghaziabad”.

SKILLS:➢ Statistical Tools: Minitab software for trending and regression.➢ Handling instruments such as HPLC, GC, UV Spectrophotometer, etc. HPLC Shimadzu,

Agilent, Shimadzu and Water’s Series Automatic and Semiautomatic with PDA, UV and Fluorescence in Empower 2, Class VP and LC solutions software, Atomic absorption spectroscopy, Gas chromatography, F.T.I.R. Shimadzu, UV Spectrometry.

➢ Routine Analysis, Developing new methods, to validate the same and fine tune the existing methods with Ensure timely AMD tests as per the set schedule of R&D stability samples. Support and submit all analytical data of development products to regulatory dept., Stability Study and Documentation.

ACHIEVEMENTS:  ➢       Attained a Gate Score of 315, Gate Card with 83 percentile in the year 2007

ACADEMIC QUALIFICATIONS: M. Pharm (Jul 2007 – Jun 2009)                          I.T.S. Paramedical (Pharmacy) College, Ghaziabad.

                                       Uttar Pradesh Technical University (U.P.)                           M. Pharm in Pharmaceutical Chemistry                           Secured a weighted aggregate of 77.7% (First Div.)

B. Pharm (Dec 2003-Jun 2007)                            Shri Ram Institute of Technology, Jabalpur                                       Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal (M.P.)

                           Secured a weighted aggregate of 68.05% (First Div.)

AISSCE 2002 (Higher Secondary)                       Christ-Church Boys Sr. Secondary School, Jabalpur (M.P)                           Secured a weighted aggregate of 60% (First Div.)

AISSE 2000 (Matriculation)                                 Christ-Church Boys Sr. Secondary School, Jabalpur (M.P)                           Secured a weighted aggregate of 63% (First Div.)

CONFERENCE & WORKSHOPS:➢       Successfully completed a 3-day workshop conducted by VLife Technologies on “Advances in Computer Aided Drug

Discovery & Design Methods” at Meerut Institute of Engineering and Technology during Aug 2008.

➢       Participated in 59th IPC held at Varanasi, December 2007.

➢       Two weeks training in Promed Lab., Indore, MP

Aim: Study the manufacturing processing of Tablets, liquid and ointment.

➢       Two weeks training in Syncom Pvt. Ltd., Indore, MP.

➢        Industrial tour in Tablet, Capsule & Ointment division of Glenmark Pharmaceuticals Pvt Ltd., Goa.

PROJECTS:

➢      Project report on “Diagnostics Kits” in B. Pharm. These kits help in detecting the Marker which was released

during the disease condition. Kits include ELISA and RIA for different disease. Its helps in the actual cause of

symptom of  disease as earlier as possible specially in viral, CVS, bacterial infection, kidney  & cancerous

complication, etc

➢      Minor-Project report on “Bird Flu” in B. Pharm. Study the history of H5N1 (flu virus) virus. How it is mutated in different region of the world and what are the precaution should be follow and new advances in treatment of bird flu medicines.