Quality Assurance Specialist (Maternity Cover)

Quality Assurance Specialist (Maternity Cover) Job ID 384530BR Italy Job Description The QA Specialist will support all the activities GMP related (operational and strategic), in order to guarantee the compliance with the regulatory requirements, quality standards and SOP in use. Your key responsibilities: Your responsibilities include, but are not limited to: • Support technological and organizational interventions aimed at the improvement of manufacturing processes in terms of quality, productivity and costs and the optimization of the resources relating to the site. • Ensure that the company manufacturing objectives and policies are consistent with GMPs. • Support the development and implementation of projects related to new or existing products. • Ensure the correct storage of Reference and Retention Samples of the raw materials and products. • Guarantee the correct labeling of storage containers for raw materials. • Approve/verify the documentation (batch record, specifications, sampling and control methods, QC procedures, protocols). • Guarantee the correct document lifecycle management (paper and electronic system). • Update the lists of documents related to the Quality Management System based on the indications of the reference SOPs. • Draft Annual Product Quality Review. • Collaborate in drafting of Site Master File and Validation Master Plan. • Manage the product complaints. • Manage CAPAs and change controls. • Handle the deviations as Certified Lead Investigator or QA Approver. • Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures. • Support the preparation and execution of internal audits and Health Authorities inspections. • Assure the execution and the proper documentation of training activities in the site. Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. What you’ll bring to the role: Education: Scientific degree Languages: English fluently, verbally and in writing Experiences: • 1 years of experience in a Quality dept. • Strong affinity with and awareness of quality issues • Good organizational skills including attention to details • knowledge of quality system (GMP) • Basic knowledge of regulatory requirements • Shows the appropriate sense of urgency around given tasks, work in team J-18808-Ljbffr