The Quality Assurance Officer supports all the activities GMP related (operational and strategic), in order to guarantee compliance with the regulatory requirements, quality standards and SOP in use, ensuring quality oversight over the entire working time of the facility for all ongoing GMP activities.
About the Role
We offer a fixed-term contract of 1 year.
Quality Assurance Officer
Major Accountabilities:
1. Supervise GMP activities in the shop floor to ensure they are carried out in accordance with GMP standards.
2. Guarantee the correct document lifecycle management (paper and electronic system).
3. Support the QP in the preparation of batch release documents as well as in the batch record closure.
4. Support the release for shipment under quarantine process.
5. Support the Artwork management process.
6. Update the lists of documents related to the Quality Management System based on the indications of the reference SOPs.
7. Management of Deviations, CAPA, and change controls as required.
8. Support the Self-Inspections as per approved annual plan.
Minimum Requirements:
1. 1+ years of experience in a Quality department.
2. Good organizational skills including attention to details.
3. Solid knowledge of quality system (GMP) and basic knowledge of regulatory requirements.
4. Availability to work in a shift pattern including night shifts.
5. Fluent in English and Spanish, written and spoken.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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