摘要
As BSO (Business System Owner), act as business representative for projects, new implementations, changes, ensuring business user requirements are setup and verified in all relevant implementation phases, guaranteeing safe, compliant and efficient manufacturing processes and use of equipment by production team.
About the Role
Key responsibilities:
- To ensure that the raw materials used for the manufacturing process are always available in the right amount and properly stored according to their status
- Support the production Manager to write down and to validate the Standard Operating Procedures and Work Instructions relating to production operations and to ensure their strict implementation.
- Be the Deputy of Production Manager in managing, coordinating and approving the execution of the production activities for the batch release when Prod Manager is not on-site. Support Production Manager to ensure proper qualification and maintenance of the manufacturing department, premises and equipment.
- Support Production Manager to ensure proper validation of relevant processes.
- Participate and contribute actively to production personnel training and validation.
- To ensure, in collaboration with Production Manager, appropriate initial and continuing training of the manufacturing department personnel.
- Manage the presence and performances of the Production Technicians when Production Manager is not on site
- To manage the re-planification of manufacturing in case of failure to mitigate the impact for the patient in collaboration with quality department when Production Manager is not on site
- Support Production Manager to improve continuously the performance through key performance indicator
- Efficient management of waste material in accordance with regulations, HSE and radioprotection standards as well as plant procedures.
- Support in Health, Safety and Environment management in collaboration with the Production Manager
- Support Production Manager on compliance activities and documentation on site with existing statutory and corporate standards in the area of regulatory compliance, cGMP, Health, Safety, and Environmental Protection.
- Collect and make synthesis of production team requirements and improvement proposals. Ensure needed production flexibility is always guaranteed.
- Contribute to definition of user requirements for changes and new implementations, guaranteeing safe, compliant and efficient manufacturing processes and use of equipment by production team.
- Contribute to all commissioning, qualification and validation phases and activities representing business perspective.
- Support preparation and execution of health authorities’ inspections and internal audits in his/her area.
- Support and actively drive continuous improvement in business processes.
Essential requirements:
- Scientific background. Degree or Master’s Degree is preferred (Pharmacy, Chemistry, Engineering, Physics, Biotechnology or similar)
- Fluent in Italian. Good knowledge of English
- 3+ years of experience in a high-tech production environment, pharma or chemical field preferred.
- Radiation safety education. Knowledge of radio-pharma processes would be a plus.
- Awareness and strong affinity with quality issues. GxP background and experience.
- Soft skills (communication, leadership, team-working, flexibility, problem solving)
- Open and clear collaboration and communication.
- Exploitation of new technology and techniques to eliminate non-value adding activities and improve productivity / performance through new processes
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.
