Qualification Expert (m/f/d)

Location: Colleretto Giacosa

Role Purpose:
Responsible to ensure compliance to cGxP standards for topics within the area of responsibility (during development, transfer, release, and stability), including safety testing, monitoring, and trending. Provide guidance, support, and leadership for the 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 business needs. Ensure readiness and release of instruments according to business needs.
• 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 the 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 the 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 the success of the 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. We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. A diverse, equitable, and inclusive environment inspires new ways of working. We can reinvent what's possible when we collaborate with courage to tackle the world’s toughest medical challenges.

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. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.