Summary
About the Role
Key responsibilities:
- 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.
- Write review, decide on approval and release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
- 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.
- Support Project management functions as a project team member
- Provide support to TRD line functions in GMP related topics as per area of responsibility
- Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
- Ensures manufacturing processes, facility, equipment and software are properly qualified and validated for GMP use.
- Generate and maintain VMP to ensure all facility, equipment, process, utilities, analytical methods, cleaning and computerized systems are qualified in compliance with regulations, standards, and specifically with GMP.
- Oversight of external parties responsible for maintenance and qualification/ re-qualification of pilot plant areas and equipment.
- Review and approve URS, DQ, IQ, OQ and PQ documentation.
- Drive continuous quality improvement program for aseptic manufacturing operations and partner with production, engineering and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed.
- Ensure review, decision and approval of all GMP deliverables.
- Approval of the whole set of documents in the area of analytical instruments and production equipment qualification and operation.
- Approval of equipment periodic reviews.
- Approval of Change Controls (CCP)
- Review/Approval of Deviations, Actions, CAPAs and Quality Events.
- Support for inspections preparation.
- Approval in document management systems
- Review of SOPs in ESOPS D2
Essential Requirements
- Bachelor Degree
- Fluent in Italian and English
- Communication skills to sufficiently address GMP and logistic related questions with line unit experts. Scientific, technical and regulatory knowledge in a specific area.
- Basic knowledge of drug development.
- Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines. Good 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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
