Qa Specialist Iii (Xico) (Valle de Chalco Solidaridad)

Responsibilities

• 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, sample 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 Mexican market in compliance with the integral quality standards and local regulations.
• Support opportunely Method Transfer activities required to ensure timely testing for first and subsequent lots to be marketed in Mexico.
• Responsible for generation & maintenance of procedures and controlled documents, (e.g. Quality Manual, SOPs, WRK, methods, etc.) ensuring alignment to integral standards & applicable integral procedures.
• Manage Quality Systems indicators: CAPA, Change Control, Internal and External Deviations, Complaints.
• Identify and elevate compliance gaps across quality systems.
• Investigate, communicate, and coordinate closure of any deviations to the quality standards, support and/or manage local investigations, ensure proper corrective and preventive actions (CAPAs) are implemented and effective.
• Support and/or manage local Change Control processes to ensure impact assessment is performed, and tasks are implemented.
• Support internal and external training initiatives in line with Gilead training strategies.
• Participate in the Annual Product Review Global Reports ensuring data related to local distribution of Gilead's products are included, as well in writing local complementary Annual Reports for marketed products in Mexico.
• Support the Quality Management Review (QMR) process, ensuring compliance with regulatory requirements applicable and opportunely communication of site metrics to senior management.
• Coordinate Import Permits with 3PL ensuring licenses are available for Drug Product, Reference Standards and Samples importation.
• Support Quality Agreements preparations and keep them updated with each partner performing the outsourced services.
• Keep the data oversight at the site level assuring full compliance with data integrity principles.
• Develop and maintain an effective working relationship with all team members and external stakeholders.
• Collaborate with cross-functional representatives to ensure timely implementation of quality records.
• Support Method Transfer and actions required for New Product Launches.
• Support internal site audits and Health Authority inspections ensuring adherence to audit schedule and timely closure of findings.
• Participate and support external audits/inspections processes to local service providers.
• Observes and enforces the Corporate Ethical Business Practices.
• Additional duties as assigned.

Experience and Skills

• Demonstrate proficiency in GMP/GDP/Good Laboratory Practices (GLPs) principles, concepts, and best practices in the Mexican and international environment.
• Demonstrate strong understanding of the applicable regulation on the Mexican market for pharmaceutical imported products warehousing / distribution / testing requirements.
• Experienced in drug product release process and