Job Description
Job DescriptionSupport implementation of Quality Strategy for Gilead Mexico and business strategies regarding product distribution, testing and release to the market.Support and conduct Quality Management System for the affiliate to comply with COFEPRIS requirements in NOM-059-SSA1; this includes but is not limited to SOPs covering all local activities, samples management, return of goods, product complaints and counterfeit, recall processes, quality risk assessments, change management, etc.Provides QA oversight to the GxP contracted organization in Mexico like Third Party Logistic Partners (3PLs) for warehousing & distribution, and Contracted Testing Laboratories (CTL) to address standard documentation and ensure GMP, GDP and GLP compliance for site readiness for inspection.Ensure efficient and effective QA support for product warehouse, transportation, testing and disposition of finished products.Responsible for documental evaluation in support to Drug Products release to the Mexi...