摘要
-Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations.
About the Role
Key responsibilities:
- Support discipline/service provision individually or within a team; provide functional expertise to QA/Line Units as needed.
- Review, approve, and release GMP-relevant deliverables and tools to ensure cGMP compliance.
- Manage project-related activities (e.g., process/quality initiatives, facility upgrades, IT validation) as per responsibility.
- Ensure compliance with internal/external quality and safety guidelines (e.g., GMP, SOPs, Quality Manual).
- Drive continuous quality improvements for manufacturing, collaborating with production, engineering, and supply chain.
- Oversee qualification/validation of processes, equipment, facilities, and software for GMP use.
- Review and approve GMP documents, including URS, IQ/OQ/PQ, Change Controls, CAPAs, and SOPs.
- Support inspection preparations and maintain oversight of external maintenance and qualification activities.
Essential requirements:
- Degree in Pharmacy, Biology, Chemistry, Engineering, or equivalent.
- Fluency in English (verbal and written).
- Strong awareness of quality issues and urgency in task completion.
- Open and clear collaboration and communication skills.
- Scientific, technical, and regulatory knowledge in the specific area, with basic understanding of drug development.
- Detailed knowledge of cGMP and familiarity with safety/environmental regulations.
- Minimum 5 years of experience in pharmaceutical companies in equivalent roles.
- Strong organizational skills.
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: https://www.novartis.com/about/strategy/people-and-culture
You will receive: You can find everything you need to know about our benefits and rewards in the Novartis Life
Handbook.https://www.novartis.com/careers/benefits-rewards
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 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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Innovative Medicines
IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
