Senior Compliance Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/86047e

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
As a Senior Compliance Specialist within the Inspections team, you will be responsible for managing all aspects of GxP regulatory authority inspections at CRG, investigator sites, and clients. however, inspection support in other regions is also in scope.
Provide consultation to project teams and clients on GxP inspection readiness, preparation, management, and follow-up activities.
Serve as the primary point of contact for inspection-related discussions with clients.
Support GxP regulatory authority inspections of CRG, investigator sites, and sponsors, including risk assessment and mitigation strategies, training of involved staff and conducting mock interviews, internal preparation, pre-inspection / mock inspection activities,



review of documentation requested by inspectors, inspection hosting and facilitation, and post-inspection follow-up.
Support project teams in investigating root causes of non-conformances and in developing CAPAs to address identified issues; follow up on action implementation, effectiveness checks, and the collection and review of supporting evidence.
Provide mentorship and guidance to junior colleagues.
Education & Experience Requirements:
Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
5+ years of quality assurance experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.
Extensive knowledge of GxP, with GCP required, along with a strong understanding of applicable regional research regulations and guidelines.
Experience with management of GxP inspections (GCP inspection experience mandato

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/86047e