Quality Assurance Manager

hace 4 semanas

Ecatepec de Morelos, México Elanco A tiempo completo
Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at Elanco. As a key member of our quality team, you will be responsible for ensuring the quality of our products and processes, while maintaining compliance with regulatory requirements.

Key Responsibilities
  • Implement and manage the Quality Management System (QMS) to ensure compliance with Elanco's international quality standards and local regulations.
  • Develop and maintain quality tools, such as Veeva and SAP, to monitor and comply with quality topics, including documentation, release of materials, training, stability studies, audits, deviations, claims, complaints, recalls, and change controls.
  • Manage resources and detect areas of investment opportunity to keep quality analytical processes updated and compliant with local regulatory requirements and Elanco's quality standards.
  • Implement and manage supplier development and control processes for raw materials, packaging materials, and GMP services to guarantee functionality in production processes and quality of products.
  • Provide direct support to regulatory processes, including audits, verification visits, and authorized professionals, to ensure compliance with local and global regulatory authorities.
  • Support site projects, such as new product development, continuous improvement, remediation, and business continuity, to ensure business continuity on site.
  • Participate in level three Huddles and manage quality incidents in global quality meetings to maintain the escalation process and seek solutions in alignment with Elanco's quality standards.
  • Provide quality support to site areas to maintain qualified and validated status of technical systems, critical and computerized systems, and production and quality processes.
Requirements
  • Bachelor's degree in Biological Pharmaceutical Chemist, Industrial Biological Pharmaceutical Chemist, Pharmaceutical Engineering, Chemical Engineering, or related fields.
  • At least 5 years of experience in quality of the pharmaceutical, cosmetic, food industry, or related, with extensive knowledge in Good Manufacturing Practices (GMP), Documentation (GPD), and Engineering (GIP), National Standards (SADER, COFEPRIS), and Data Integrity guidelines.
  • Extensive experience in quality systems management in the pharmaceutical/chemical industry or related fields.
  • Advanced knowledge in Continuous Improvement, Lean Manufacturing, and Statistical processes tools focusing on the pharmaceutical/chemical industry or related fields.
  • At least 5 years of experience in training processes and management of high-performance work teams in areas of health and the chemical/pharmaceutical industry.

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