Bhavesh Patel has over 5 years of experience in quality assurance, quality control, and analytical method development using HPLC. He has a strong background in auditing and ensuring compliance with regulations from agencies like USFDA, WHO, and MHRA. His experience includes preparing SOPs, conducting audits, developing and validating analytical methods, stability testing, and serving as a training coordinator to ensure employees receive necessary GMP and GLP training. He has a M.Pharm in Pharmaceutical Chemistry and skills in statistical tools, instrumentation like HPLC and GC, method development and validation.

1. BHAVESH PATEL 535 Alabama Avenue, Ronald McDonald House
Memphis TN USA 38105
E-mail: bhavla83@gmail.com
Phone 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.

2. 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).
ResearchAssociate, Indian Veterinary ResearchInstitute 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.
Masterin 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.)

3. 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.