Keyur Mistry Email & Phone Number

Canada

Execute method transfer and method validation activities for Raw Material, Finished Intermediate and Finished Product, as per requirements established in the related protocols, SOPs and ICH guidelinesPlan, coordinate and execute analytical method and equipment cleaning (Rinse and SWAB) validation, as per GMP and regulatory requirements to meet defined timelines Create or revise technical and quality documents for the department such as analytical methods, Validation protocols, and Validation reports or summaries after validation or verificationRecognize, report and conduct immediate action for any OOS, deviation and Anomalous test results, instrument malfunctions and methodology problems during analysisReview analytical data for accuracy of validation results as generated by team members, as requiredReview Analytical Method, Validation protocols and reports/summaries by assessing technical accuracy, completeness, and compliance to internal procedures and GMP Execute Change control activities for new or revise analytical methods during method validationInitiate Lab Investigation Report, OOS and deviation using TrackWise and conduct or assign investigations activities on a timely mannerInitiate and Support Continuous Improvement Activities to improve the laboratory/department efficiency and deviation reduction, such as creating instrument job aids, training modules for new hire, SOP simplificationParticipate in Compendial Compliance Working Group to ensure analytical methods/procedures and SOPs are in compliance with the pharmacopoeias and regulatory authorities Actively participate in the process of identifying, reporting and assisting in eliminating risks to health and safety in the workplaceParticipate in internal, customer and regulatory audit as SME for different techniquesActively conduct monthly laboratory inspection of all potential safety hazard as Safety Committee member

Brandford, On

Execute Sampling and physical/chemical testing of RM, FI, FP and R & D samples for APIsCommunicate and plan testing of IPT & ECV samples to support production, while managing laboratory schedule and prioritiesProcess and integrate chromatographic data and accurately perform complete documentation of analytical data, results and information under GDPReport all testing results and deviations encountered during testing in a timely mannerRecognize and report any OOS or OOT test results and Conduct OOS / non-conformance investigation activities and assist in analytical method development in compliance of GMPRelease, retain and maintain records of Raw Materials, Intermediates and Finished Products upon approval of resultsAccurately perform complete documentation of analytical data, results and information according to GLP guidelinesPerform method transfer activities and draft operational SOP for PolarimeterPerform calibration, troubleshoot and preventative maintenance of laboratory equipment as requiredReview lab documentation such as laboratory logbooks, worksheets, instrument daily calibrations, ECVRs as requiredActively participate in process of identifying, reporting and assisting in eliminating risks to health and safety in the workplaceProvide mentoring, training and assistance to junior chemists and co-op students

Mississauga On Canada

Prepared and Analyzed soil, water, oil and waste water samples for testing of VOCs, BTEXs and HCs by using Chromatography techniques as per SOP Proficient in day-to-day Analysis of data and Report Results using a LIMS without any mistakesPrepared and documented chemical solutions, reagents and calibration standards for lab analysis as per standard practicesPerformed maintenance and troubleshooting of Laboratory equipment and apparatusMaintained and organized records of prepared standards, calibration data, daily QC and control charts of instrumentsImplemented Preliminary Lab Investigation under lab manager to resolve customer complaints and generate workable solutionCo-operated with Quality Assurance auditors during laboratory inspectionsActively executed weekly inspection of all potential health & safety hazard, while handling waste disposal as team leader

India

Performed IPQA tests for oral & parenteral dosage forms, as well as conducted routine check on production activities to ensure all work is performed in full compliance with GMPPresented in manufacturing and Fill Finish areas and provided on floor support to productionPerformed Room Release/ Change over – Approval / Line Clearance as required by production as per SOPExecuted Visual inspection and real time batch record review on the floor during manufacturing processPerformed immediate assessment of impact and criticality of all events and made decision to continue or stop production or packaging activitiesReviewed executed Batch Records like BPR, Buffer / Solution forms, other documents associated with batch manufacturing for various dosage forms if requiredEnsured testing and reporting results complies company policies and regulatory requirementsParticipated in safety and quality audits and maintained Quality Unit all time ready for audit

Bachelor'S Degree, Pharmacy, First Grade

Activities and Societies: Volunteer work in Pharmaceutical industry for 6 Months

Diploma, Chemical Laboratory Technology/Technician, Honors

Activities and Societies: Smile Mentoring Guided two newcomers in Seneca under Smile Mentoring Program to enhance their personal.