摘要
This role will work directly with the Quality and Operations Team, and reports to the QA Operational Manager.
About the Role
Major accountabilities:
- Prepare and perform QA review of batch release documents and supports the Quality Responsible with the batch release process, as well as guarantee the correct document lifecycle management (paper and electronic system).
- Release of starting materials and incoming goods.
- On-site Quality support for operational activities including interventions.
- Approve and review quality related documentation (operational procedures, protocols, and work instructions), and ensures archiving of batch documentation.
- Supports with deviation management. Ensures that the appropriate impact assessments are performed in a timely matter as well as the deviations are closed promptly.
- Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures.
- Supports with CAPA’s, change controls, preparation and execution of internal audits and Health Authorities inspections, and also support in improvement projects.
Minimum Requirements:
- MBO/HBO level, preferably in a scientific field.
- Knowledge of quality system (GMP), and basic knowledge of regulatory requirements.
- English fluent, verbally and in writing
Desirable Requirements:
- Experience with radiation, PET or radiopharmaceuticals.
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! Learn More Here
http://www.novartis.com/about/strategy/people-and-culture
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.
Join Our Novartis Network
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about
Novartis and our career opportunities, join the Novartis Network here: http://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
