摘要
Role Purpose:
Responsible to ensure compliance to cGxP standards for topic within area of responsibility (during development, transfer,
release and stability), including safety testing, monitoring and trending.
Provide guidance, support and leadership for implementation of analytical standards.
About the Role
Main Responsibilities:
Operational
- Project leader for initial qualification of laboratories, associated analytical instruments and systems; Approves qualification documents, if applicable
- In charge of planning the qualification activities according to the business need. Ensure Readiness and release of Instruments according to the business need
- Ensure qualification/calibration status of analytical equipment and associated utilities and facilities (Alarm management, Pest control…)
- Change Control: Initiator and Owner of Change requests associated with laboratories implementation; Initiator, Owner and Approver of CAPA and Task Loop
- Author and Reviewer of SOPs within area of responsibility.
- Ensure laboratories are maintained according to cGxP standards. Ensure compliance of analytical laboratories and development according to applicable regulatory requirements and guidelines
- Ensure overall inspection readiness for area of responsibility and Contribute to GxP audits/inspections. Ensure methods and procedures are up-to-date
- Management of documentation and methods according to cGxP.
Leadership & Culture
- Support the organization by identifying and reviewing the appropriate list of training for all in-scope associates
- Ensure that associates are qualified for a GMP task prior to independent performance
- Monitor overall training compliance for in-scope associates
- Identify and maintain a list of subject matter experts for in-scope areas of expertise
- Create a work environment that enables high employee engagement
- Role model the culture aspiration of being Curious, Inspired and Unbossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do at Novartis!
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
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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.
