Arpit Patel Email & Phone Number

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Vadodara, Gujarat, India

Generation, progress tracking, extensions, and closure of QMS documents such as Deviation, CAPA, OOS, OOT, and Lab investigations.Initiation, review, and propose actionable for Change controls of the analytical laboratory activities.Involved in the investigation of laboratory incidents, OOS, OOT, and Deviation from a quality perspective.Quarterly and six-monthly trending of QMS documents such as OOS, OOT, and Lab investigations.Preparation of APRs by incorporating Analytical data of respective products.Liaison with RA team for actionable documents required for regulatory filings, post-approval changes and annual product reports.Review of Analytical Method Validation Protocols, Addendums, Raw Data, and Reports of ANDA.Raw Data review of Raw Materials, In-process, Finish Goods, and Stability Samples that involves laboratory notebook, instrument software, and usage log books.Liaison with QC teams for the implementation of CAPA and its risk assessments.Approving the release of QC samples after fulfillment of analytical testing in LIMS.Support QA management as required

Ahmedabad

Analytical Method Development for ANDA Submissions - Actively developed methods related to Impurity Profiling, Assay, and chiral chromatography of drug products.Assisted Formulation R&D in optimizing batch CQA by conducting R&D Sample testing and stability samples testing.Strong understanding and evaluating skills for Stress Studies, Transportation studies, and Stability studies on raw materials and finished productsInvolved in troubleshooting and resolving moderate development issues, and chromatographic queries from the QC team, as requiredAnalytical activity with respect to the U.S. FDA query responsePreparation and review of analytical method verification, validation, and equivalency protocols for successful execution in the CMC environmentInvestigation for laboratory incidents reported in the CMC laboratory

Vadodara

Protocol preparations and execution of Analytical Method Validations of dosage forms such as injections, tables, capsules.Expertise in Forced Degradation studies to prove stability indicating methods.QMS investigations such as Laboratory deviations, Out of calibration and other GLP quality documents.

Goa

Execution of Analytical Method Validations, pre-formulation, drug-excipient compatibility studies, scale-up batch analysis.In-vitro dissolution profile comparison of ANDA with the Innovator Product.

Master Of Science - Ms, Regulatory Affairs, 3.74 Gpa

Importance of regulatory documentation and records Submission pathways for Drug Products (Drugs, Biologics, and Medical devices).

Master'S Degree, Pharmacy, First Class

Activities and Societies: Submitted thesis on Impurity Profile Method Development of Lansoprazole

Bachelor'S Degree, Pharmacy, Distinction

Education record