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).
Tasks And 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
* University degree in Chemistry, Biochemistry, Biology, Microbiology, Pharmacy, or an equivalent field
* Minimum of 5 years of experience in aseptic processing and APS (Annex I EU GMPs, 2004 FDA Guidance for Industry, etc.) is essential
* Fluent spoken and written English and Spanish is required for participation in global meetings and for understanding, reviewing, and approving project documentation
* Desirable knowledge of software such as PAS-X, EWM, SAP, SCADA
* Experience with Combination Products (syringe + AI / PEN) is a plus
* Proactive individual with strong adaptability, flexibility, fast learning ability, autonomy, and excellent communication and interpersonal skills
IamBoehringerIngelheim because…
We are continuously working to design the best experience for you. Here are some examples of how we will take care of you:
* Flexible working conditions
* Life and accident insurance
* Health insurance at a competitive price
* Investment in your learning and development
* Gym membership discounts
If you have read this far, what are you waiting for to apply? We want to know more about you
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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