Dignesh J Patel216-291, St. Anne’s road,

Winnipeg, ManitobaPhone: (204)-890-2436

Email: digneshpatel_03@yahoo.co.in

Education

Post Graduate Diploma in QA/QC in Pharmaceutical Industry Sept. 2010 – PresentRed River College, Winnipeg

Bachelors in Pharmacy Sept.2006 – Aug. 2009Rajiv Gandhi University of Health Sciences, India

Diploma in Pharmacy June 2001 – April 2003Gujarat 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 2010Cadila 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 2006Anand Medical Store, India

Handled the Prescriptions, executed purchase order Maintained and controlled inventory, billing cycle and other relevant documents

References

Provided upon request