摘要
1. Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility
2. Write review, decide on approval and/or release of GMP-relevant deliverables, as applicable, and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
3. Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
4. Support Project management functions as a project team member.
5. Provide support to TRD line functions in GMP related topics as per area of responsibility.
6. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
About the Role
Key responsibilities:
- Support the TRD QA function within a team, providing expertise to Line Units and other QA units in areas of responsibility.
- Write, review, and ensure compliance of GMP-relevant deliverables and tools with cGMP standards and project quality requirements.
- Oversee quality assurance for technical activities during development stages, including technical transfers and release requirements.
- Support project-related activities such as process development, quality initiatives, risk assessments, facility upgrades, and IT validation.
- Ensure alignment and consistency of regulatory submissions (IMPD/IND, NDA/MAA) and address health authority queries.
- Assist clinical trial teams with QA activity timelines and supply chain oversight.
- Perform QMS-related activities, including training, KPI oversight, SOP maintenance, and audit/inspection support.
- Act as QA point-of-contact for assigned CMO, including audits, CAPAs, documentation reviews, and compliance monitoring.
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: http://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.http://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: 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
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.
