QA Aseptic Project

Overview

As part of the Quality Stream Aseptic Project structure and reporting directly to the Quality Stream Lead, the QA Aseptic Project will be responsible for supporting decision-making processes related to quality requirements during the design phases of Dispensing, Compounding, Filling (isolator), and auxiliary equipment for the project (Grade C environment).

Responsibilities

• Support decision-making regarding quality requirements during the design phases of Dispensing, Compounding, Filling, and auxiliary equipment for the aseptic project
• Participate in the drafting, review, or approval of documents resulting from decisions made during the project design phases (e.g., rationales, risk analyses)
• Review and approve documents related to the qualification-validation lifecycle of production equipment, process and cleaning validations, laboratory equipment, computerized systems, analytical method validations and transfers, utilities, and facilities, in accordance with cGMP, corporate, and local procedures
• Ensure cGMP and regulatory compliance (FDA, EMA (Annex I), China, Japan, etc.) of all associated documents and workflows
• Participate in follow-up meetings with Local – Global functions in order to align key decisions and procedures
• Collaborate in the development of new EBR - electronic batch record from the design phases prior to PPQ – Validation through to routine stages in Compounding, Dispensing, Filling, and auxiliary equipment (including Machine Integration)

Requirements

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We would like to inform you that your application will be processed, but the contact from the recruitment team will not take place before September. We appreciate your understanding and patience.

Nuestra compañía

En Boehringer Ingelheim desarrollamos tratamientos innovadores que mejoran la vida de las personas y de los animales. Fundada en 1885 y de propiedad familiar desde entonces, Boehringer Ingelheim adopta una perspectiva a largo plazo. En la actualidad, contamos con empleados en todo el mundo que fomentan una cultura diversa, colaborativa e integradora. Creemos que si contamos con personas talentosas y ambiciosas, apasionadas por la innovación, no hay límite a lo que podemos lograr.

Por qué Boehringer Ingelheim?

Con nosotros puedes crecer, colaborar, innovar y mejorar vidas.

Ofrecemos un trabajo estimulante en un entorno laboral global respetuoso y cordial, rodeado de un mundo de mentalidades y prácticas impulsadas por la innovación. Además, el aprendizaje y el desarrollo de todos los empleados es clave, porque tu crecimiento es nuestro crecimiento.

Boehringer Ingelheim es una empresa global que ofrece igualdad de oportunidades y se enorgullece de mantener una cultura diversa e inclusiva. Aceptamos la diversidad de perspectivas y nos esforzamos por crear un entorno integrador, que beneficie a nuestros empleados, pacientes y comunidades.

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