Senior Quality Assurance Manager

hace 4 semanas


Santiago de Querétaro, Querétaro de Arteaga, México Gerresheimer A tiempo completo

Job Description

At Gerresheimer, we are seeking a knowledgeable and experienced Quality Assurance Chief to lead our implementation and coordination of QMS according to industry standards and guidelines.

Responsibilities

  • Lead the implementation and maintenance of our QMS in accordance with NOM-059-SSA1-2015, NOM-241-SSA1-2021, CRF 21, ICHs, and pharmaceutical industry guides.
  • Coordinate quality management activities, including AMEF, CAPA, change controls, internal and external audits, RAP, and other quality-related tasks.
  • Develop and manage process performance KPIs and QMS, ensuring compliance with industry standards and regulatory requirements.
  • Foster a culture of quality and excellence within our organization, promoting results-oriented decision making and assertive communication.
  • Maintain a deep understanding of the pharmaceutical industry and its regulations, including NOM-059-SSA1-2015, NOM-241-SSA1-2021, CRF 21, and ICHs.
  • Ensure the effective use of problem-solving tools, including Pareto diagrams, Ishikawa, and control charts.
  • Collaborate with cross-functional teams to drive quality improvements and ensure the delivery of high-quality products.
  • Maintain a conversational level of English (B2) and proficiency in SAP and Microsoft Office.


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