TRD Sr. QA Specialist

Job description

Job Description Summary Location: Ivrea, Italy #onsite Role Purpose: Support the pilot plant ramp up and operationalization process through the creation compliant manufacturing and QC-related quality system which comprises master batch records, logbooks, forms, procedures. Support qualification and validation activities managing and reviewing the related documentation. Ensure the compliance of all the business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, in preparation of external and corporate audits and Health Authority inspections. Maintain the site compliance through 3rd party management, trainings, change controls, self-inspections, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators) monitoring. Job Description: Major Accountabilities: Support site qualification and validation activities (advising, review, approval). Implementation of Quality Systems (incl. documentation management) Supplier management activities (agreements, oversight, audit). Preparation/support and coordination of CAPA/follow -up Audit and inspection preparation and support, ensure applications, certificate maintenance etc. to l...