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QA Release Officer

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Novartis

11d ago

  • Job
    Full-time
    Junior Level
  • Healthcare
  • Barcelona

AI generated summary

  • You need a degree in Health Sciences, 1+ years in Quality Assurance/Control, strong GMP knowledge, and proficiency in Spanish and good English.
  • You will manage quality aspects, ensure GxP compliance, review batch documentation, initiate EU Batch Certificates, prioritize releases, oversee lot reconditioning, and report monthly indicators.

Requirements

  • Licenciatura en Ciencias de la Salud
  • 1+ años de experiencia en Garantía de Calidad y/o Control de Calidad.
  • Alto conocimiento de las GMPs y procesos de fabricación de medicamentos.
  • Español nativo y Inglés nivel bueno

Responsibilities

  • Gestión aspectos de Calidad y proyectos dentro del área de responsabilidad.
  • Garantizar y respaldar la conformidad general de GxP y el cumplimiento de los sistemas de gestión de calidad de Novartis
  • Realización de la revisión de la documentación de lote previa a la liberación por parte del QP.
  • Iniciación y obtención del EU Batch Certificate de los productos centralizados. Evaluación del transporte de medicación comercial y valoración en caso de excursiones de temperatura.
  • Gestión y priorización de las urgencias y liberaciones.
  • Gestión del reacondicionamiento de lotes comerciales conforme a GMPs.
  • Asegurar la implementación de SLC conjuntamente con Supply, DRA y otros departamentos relacionados.
  • Reporte y seguimiento de los indicadores mensuales y gestión docuteca y muestroteca.

FAQs

What is the duration of the contract for the QA Release Officer position?

The contract for the QA Release Officer position is temporary for a duration of 1 year.

What educational qualifications are required for this role?

A bachelor's degree in Health Sciences is required for this role.

How many years of experience in Quality Assurance or Quality Control are necessary to apply?

A minimum of 1 year of experience in Quality Assurance and/or Quality Control is required.

What languages do I need to be proficient in for this position?

Fluency in Spanish is required and a good level of English is also necessary.

What key responsibilities will I have in the QA Release Officer role?

Key responsibilities include managing quality aspects and projects, ensuring GxP compliance, reviewing batch documentation, obtaining EU Batch Certificates, and reporting on monthly indicators.

Is there any specific knowledge required regarding manufacturing processes?

Yes, a strong understanding of GMPs and drug manufacturing processes is essential for this position.

What benefits does Novartis offer to employees in this position?

Novartis offers a competitive salary, a variety of social benefits including pension plans, free medical insurance, subsidized meals, life and accident insurance, gym discounts, training programs, and leadership development opportunities.

Where is the QA Release Officer position located?

The position is located in Barcelona, Spain.

Is this role full-time or part-time?

This role is a full-time position.

Will I be involved in training programs and development opportunities?

Yes, the role includes access to training courses, English language programs, and leadership development training for managers.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right