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Senior Compliance Specialist

1 mese fa

Roma, Lazio, Italia Advanced Accelerator Applications (Italy) - S... A tempo pieno

Job Summary:

As a Senior Compliance Specialist at Advanced Accelerator Applications, you will be responsible for ensuring compliance to cGxP standards for topics within your area of responsibility. This includes safety testing, monitoring, and trending, as well as providing guidance, support, and leadership for the implementation of analytical standards.

Main Responsibilities:

  • Operational Project leader for initial qualification of laboratories, associated analytical instruments, and systems
  • Approves qualification documents, if applicable
  • Ensures readiness and release of instruments according to business need
  • Ensures qualification/calibration status of analytical equipment and associated utilities and facilities

Change Control:

As a Senior Compliance Specialist, you will be responsible for initiating and owning change requests associated with laboratory implementation, as well as initiating, owning, and approving CAPA and task loops. You will also be responsible for authoring and reviewing SOPs within your area of responsibility, ensuring laboratories are maintained according to cGxP standards, and ensuring compliance of analytical laboratories and development according to applicable regulatory requirements and guidelines.

Culture and Leadership:

You will support the organization by identifying and reviewing the appropriate list of training for all in-scope associates, ensuring that associates are qualified for a GMP task prior to independent performance, and monitoring overall training compliance for in-scope associates. You will also identify and maintain a list of subject matter experts for in-scope areas of expertise, create a work environment that enables high employee engagement, and role model the culture aspiration of being curious, inspired, and unbossed.

About Us:

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, and 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.