Job Description
Job Description
- Support 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 evalu...