Jatin Kumar

Quality Specialist- 3pl and Quality Consultant @McKesson

Milton, ON, CA

Responsible for review of all batch release documentation to support product release in Canada for MSD imported products/QA consulting clients, including MRA/non-MRA drugs. • Responsible for implementing and maintaining effective cGMP complaint Quality system processes and processes. Maintaining active Quality Assurance Agreements (QAAs) with the client and related 3rd parties for all importation products. • Responsible for initiation and completion of complaint investigations, deviations (planned and unplanned), change controls, CAPA for all QA Consulting clients. • Responsible to present Quality Systems during regulatory audits as required. • Review of stability protocols/reports, media fill studies, APQRs, and preparation of APQR addendums. • Main QA contact for clients assigned, and responsible for all GMP activities required to support client with ensuring GMP compliance. • Responsible to provide oversight of assigned quality system and related business processes with respect to developing quality metrics and feedback on enclosing gaps with effective communication between internal and external stakeholders. • Responsible for review of receiving documents and final release in warehouse management system following release from 3-PL clients. • Provide Quality Assurance guidance and support to potential new clients or new products as assigned • Prepares and updates SOPs and WIs as required. • Executing special QA projects, including secondary packaging, and labelling for Investigational products (clinical).

Punjab Technical University

Bachelor's of Pharmacy