The document contains the resume of Dignesh J Patel. It outlines his education including a Post Graduate Diploma in QA/QC from Red River College in Winnipeg, a Bachelors in Pharmacy from Rajiv Gandhi University of Health Sciences in India, and other qualifications. It also lists his technical skills such as ensuring compliance with regulatory requirements, statistical analysis, and operating various lab instruments. His work experience includes being an RA Apprentice at Cadila Healthcare Ltd. in India and working as a Pharmacist at Anand Medical Store in India. References are available upon request.
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The document contains the resume of Dignesh J Patel. It outlines his education including a Post Graduate Diploma in QA/QC from Red River College in Winnipeg, a Bachelors in Pharmacy from Rajiv Gandhi University of Health Sciences in India, and other qualifications. It also lists his technical skills such as ensuring compliance with regulatory requirements, statistical analysis, and operating various lab instruments. His work experience includes being an RA Apprentice at Cadila Healthcare Ltd. in India and working as a Pharmacist at Anand Medical Store in India. References are available upon request.
The document contains the resume of Dignesh J Patel. It outlines his education including a Post Graduate Diploma in QA/QC from Red River College in Winnipeg, a Bachelors in Pharmacy from Rajiv Gandhi University of Health Sciences in India, and other qualifications. It also lists his technical skills such as ensuring compliance with regulatory requirements, statistical analysis, and operating various lab instruments. His work experience includes being an RA Apprentice at Cadila Healthcare Ltd. in India and working as a Pharmacist at Anand Medical Store in India. References are available upon request.
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as DOCX, PDF, TXT or read online from Scribd
The document contains the resume of Dignesh J Patel. It outlines his education including a Post Graduate Diploma in QA/QC from Red River College in Winnipeg, a Bachelors in Pharmacy from Rajiv Gandhi University of Health Sciences in India, and other qualifications. It also lists his technical skills such as ensuring compliance with regulatory requirements, statistical analysis, and operating various lab instruments. His work experience includes being an RA Apprentice at Cadila Healthcare Ltd. in India and working as a Pharmacist at Anand Medical Store in India. References are available upon request.
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as DOCX, PDF, TXT or read online from Scribd
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