Sammanfattning
About the Role
Major Accountabilities:
- Support general compliance activities in line with departmental needs (e.g., act as SOP manager, training responsible person, 1QEM key user; support KQI reporting and quality monitoring, and QMS implementation).
- Support third party management–related processes, including administrative and system support (e.g. site ID creation, system verifications, dashboards, data management, due‑date tracking and communications).
- Support third party oversight related activities, including audit administration review of third-party GMP documentation and BD&L deals.
- Author and review GxP documentation.
- Support the filing and archiving of GxP records in accordance with applicable procedures.
- Contribute to continuous improvement of compliance and third-party management processes.
- Support project-related activities (e.g., developing new tools and implementing new processes).
Work Experience:
- Quality compliance & Quality Management Systems (GxP; strong GMP focus).
- Third-party quality management & oversight (qualification, documentation review, audit support, issue follow-up).
- Drug development / R&D exposure (preferred).
- Corrective and Preventive Action (CAPA) knowledge
English.
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
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
