About the Role
The Qualified Person will be in charge of the release of batches of pharmaceutical products for human use in accordance with the relevant requirements and the European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use).
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Release the batches of radiopharmaceuticals produced according to Directive 2001/83/EC for Medicinal products for human use and National laws.
• Be the Point of Contact with the Competent Authorities during inspections and execute the operations required.
• Certify the production operations on suitable documentation and have responsibility for their conservation/updating.
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• Work in shift with other QPs to supervise the production and quality control activities.
• Being available for the assessment of OOS and deviations that occurs during the batch production and quality control.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Role Requirements
What you'll bring to the role:
• Scientific Degree (CTF, Pharmacy or Chemical Sciences).
• Italian: Proficient. Good knowledge of English.
• Ministerial Qualification as a Qualified Person released by AIFA.
• Background in a sterile/radiopharmaceutical manufacturing environment will be considered a plus.
Work Location: Colleretto Giacosa (TO).
Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://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? https://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: https://talentnetwork.novartis.com/network
Division
Oncology
Business Unit
ADVANCED ACCELERATOR APPLICATIONS
Location
Italy
Site
Colleretto Giacosa
Company / Legal Entity
AAA Italy Srl.
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
Yes