Farida Kafaei Email & Phone Number

-Conducting Internal Audit for different sites at ELC.• Participate in FDA, Health Canada, ISO Audit and Corporate Audit.• Preparing Site Reference Files for different sites at ELC.• Leading Annual Summary Reports preparation for all OTC products.• Managing change controls, CAPA, Deviation requests and related trending.• Review and approval of validation protocols and reports. (IQ, OQ, PQ)• Review and approval of all temperature monitoring study and reports.• Spearhead and manage the GMP Training (New hires and continuous training for ELC, CADC employees).• Data steward for SOP databaseManage the Quality responsibilities associated with product launch and release product per assigned portfolio:• Including Importation, Receiving-inspection, Sampling and Testing, SAP process, Submission documentation Review, Product release for MRA, non-MRA countries including drug products and Medical devices• Compliance Certificates review, CoA, CoM, Specification Documents and Batch Record.• Communicate and collaborate with third parties on issues, deviations and corrective/preventative actions related to product distributed in Canada.• Manage change controls and their associated tasks and evaluate change controls for their impact• Provide review and support of tasks related to launching of new products.• Initiate and/or approve process and product deviations per applicable quality system. Investigate and implement mitigation actions as necessary.( issue IDP and product defect evaluation and compliant report)• Evaluate product returns from hospitals or Home patient and provide required product disposition based on available data.• Manage and maintain organization (Filing) of all quality documents, upload and organize documents in ECM.• Provide product disposition based on available stability data and allowable excursion temperature data when applicable. • Manage closure of applicable deviation in the timeframe required per applicable quality system.

Listed skills include Gmp, Pharmaceutical Industry, Sop, Hplc, and 17 others.