Dignesh J Patel

216-291, St. Anne’s road,

Winnipeg, Manitoba
Phone: (204)-890-2436
Email: digneshpatel_03@yahoo.co.in

Education

 Post Graduate Diploma in QA/QC in Pharmaceutical Industry Sept. 2010 – Present

Red River College, Winnipeg
 Bachelors in Pharmacy Sept.2006 – Aug. 2009
Rajiv Gandhi University of Health Sciences, India
 Diploma in Pharmacy June 2001 – April 2003
Gujarat University, India
 Grade 12, Science Stream June 2000 – March 2001

Technical skills

 Ensure compliance with ICH-GCP, GLP and other regulatory requirements

 Execute statistical methods to evaluate laboratory testing data and to assess test results
 Interpret and practice the principles of GDP
 Compare and Evaluate dissolution profile data using statistical f2 method in BE study
 Review patient eligibility for enrolment in clinical trial
 Verify routine performance of Analytical Instruments and maintain the logs for the same
 Operate UV/VIS spectrophotometer (Shimadzu), pH meter (Orion), FTIR (Perkin Elmer),
Gas Chromatography (Agilent), HPLC (Waters), TOC Analyzer and Beckman CE
system.
 Interpret the regulations and compile the documents for regulatory submission
 Resolve and Respond to the queries on regulatory submission
 Review Finished Products Data and Raw Materials Data using SAP system.
 Review the technical documents like Batch Records, Stability Reports, dissolution profile
comparison data, method validation, process validation protocol
 Skills in MS-Office; word, power-point, excel
 Retrieved various pharmacological and chemicals data from pharmacopoeias and
various website.
 Interpret the regulations for Package Insert and other labeling requirements and ensure
the compliance of the same with regulations.
 Prepare the registration dossier for Philippines, Sri Lanka, Myanmar and Vietnam
 Handle the prescriptions in Hospital Pharmacy and maintain the relevant documents
using software Medi-soft
Work Experience

 RA Apprentice October 2009 – June 2010

Cadila Healthcare Ltd., India

 Coordinated for collection of various manufacturing and chemical data

from respective departments such as Validation, QC, QA, Production,
Formulation and Development and reviewed them.
 Prepared Product dossiers of different dosage forms for international markets
 Resolved and responded the queries on regulatory submission within limited time
frame.

 Pharmacist Jan. 2004 – June 2006

Anand Medical Store, India

 Handled the Prescriptions, executed purchase order

 Maintained and controlled inventory, billing cycle and other relevant documents

References

 Provided upon request