Iseeta Patel Email & Phone Number

Ontario, Canada

Cambridge, Ontario, Canada

Cambridge, Ontario, Canada

Toronto

• Experienced in AssurX Quality Management System and AS400 • Reviewed and documented all MDPRs and forwarded to respective authorities when required• Trained the new members regarding department process of handling complaints, MDPRs and Recall• Reviewed all medical device licences and updated licences as required, DEL, MDEL, MD licence• Managed QA holds• Coordinated and documented on Pharmacovigilance process and medical device Mandatory Problem reporting• Handled Recall in timely manner and submitted the data to health Canada, notified customers in timely manner and close the recall in timely manner• Prepared any regulatory change to the drug product and medical device, including manufacturing process• Received, Evaluated and entered complaint in QMS system within specified time period • Followed up and review complaints require CAPA and closed complaints in timely manner• Identified potential MDPR, gathered information regarding it and submitted to health Canada• Prepared SOP for Complaints, Recalls and MDPR Process• Supported and maintained a process that will ensure all requirements from Health Canada are met• Worked as a supporting member of Regulatory Affairs team in licencing project to reassess the device class in the modular system.

Oakville, Ontario, Canada

• Experienced in AssurX Quality Management System and AS400 • Reviewed and documented all ADRs and forwarded to respective authorities when required• Reviewed all medical device licences and updated licences as required, DEL, MDEL, MD licence• Managed QA holds• Coordinated and documented on Pharmacovigillance process and Medical device Mandatory Problem reporting• Handled Recall in timely manner and submitted the data to health Canada and notified customers in timely manner• Prepared any regulatory change to the drug product and medical device, including manufacturing process• Received, Evaluated and entered complaint in QMS system within specified time period• Followed up and close complaints in timely manner• Identified potential MDPR, gathered information regarding it and submitted to health Canada• Prepared SOP for Complaints, Recalls and MDPR Process• Supported and maintained a process that will ensure all requirements from Health Canada are met• Worked as a supporting member of Regulatory Affairs team in licencing project

Mississauga, Ontario, Canada

• Performed work like capping, cartoning, packing shippers and palletizing according to good manufacturing practices • Performed In process Testing, Sensor challenge, Analytical balance verification, Torque verification in Primary Packaging area• Inspected finish product for presence and correctness of lot number, expiry date and general appearance• Performed duties according to standard operating procedures (SOPs) and packaging instructions• Worked at line speed with minimal supervision

Ontario, Canada

• Answered customer calls promptly and operated the register when needed• Ensured the department fully stocked with merchandise and is ready for business• Performed binning, picking and zoning of the products • Ensured the merchandise is properly signed and priced• Handled drop-off and pick-up of prescription• Filled the prescription hard copies by using KROLL software

India

• Reviewed scientific and legal, and foreign regulatory documents• Gathered, evaluated, organized, and collected lab results to create certificate of analysis Planned, undertook and oversaw product trials and regulatory inspections• Kept up to date with changes in regulatory legislation and guidelines• Analyzed complicated information, including trial data for new drug products• Coached and trained co-workers on company policies, practices and systems• Obtained marketing permission by completing all documentation and sign-off• Used a variety of specialized computer applications (SAP, database programs, LIMS)• Ensured that quality standards were met and submissions met strict deadlines• Prepared Out of specification and Out of trend reports and review them• Experienced in Dossier Preparation [SNDSs, NDSs] for Drug products for US, EU and Mexico (eCTD filling)• Prepared documents based on requirement for new product submissions Pre-market and Post- market submission• Co-ordinated with R&D and quality department to compile trend data preparation, Country specific document preparation for regulatory body

India

• Analysed all samples manufactured by company (physical and chemical tests)• Prepared documents that indicate the result of product testing• Prepared Standard Operating Procedures and Test Method Specification for quality control department• Analysed samples by using HPLC, TLC, PH-meter, Friability tester, Dissolution samplers• Analysed R&D samples and prepared documentation • Handled and reviewed stability sample documentation• Prepared SOPs and distributed them according to QA documentation system• Handled Change control and Deviation• Performed stability equipment validation (IQ, OQ and PQ)• Assisted QA manager in hosting Audits from GMP clients

Post Graduate, Quality Assurance And Regulatory Affairs

• Obtained knowledge of GMP level I, II and III, Audit Level I and II, Regulatory affairs in Food, cosmetic, Pharma industry (Drug.

Bachelor Of Pharmacy-Bpharm, Pharmacy