Steriles Quality Assurance
PHARMA QUALITY EUROPE
Ciudad de Mexico, México
hace 3 días
source : PMFARMA

Descripción : Due to a constant growth, we are currently looking for a Quality Assurance Specialist with experience in the Injectable area.

Responsibilities

  • Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.
  • Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.
  • Write, review, approve, and implement procedures, specifications, processes, and methods as required.
  • Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
  • Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.
  • Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.
  • Liaise with internal and external inspectors and representatives, particularly on QA-related topics.
  • Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained.
  • Identify to management problems in personnel, equipment, and the facility that require correction.

    Edad máxima para el puesto : 40 años.

    Requisitos :

  • Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.
  • Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g. gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP / FDA regulations.
  • Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.
  • e. follow and maintain corporate CAPA, deviation, and OOS protocols).

  • Ensure product complaints are handled in a manner consistent with Company SOPs and FDA regulations.
  • Nivel de estudios mínimo requerido : Licenciado Nivel de Inglés mínimo requerido : Leído : Bueno Escrito : Bueno Hablado : Bueno Experiencia profesional mínima requerida : 3 años Disponibilidad para viajar requerida : El 100% del tiempo laboral

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