Quality Unit Manager
- Chivasso, Italy
AAA Statement Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).
The Quality Unit Manager leads the Quality function to ensure that all aspects of the operational business comply with cGMP, legal and regulatory requirements and the AAA-Gipharma Quality Manual and Policies. To ensure implementation, follow up and completeness of all related Quality/ Compliance programs, documentation and Quality reporting. To ensure that a proper escalation & quality incident management process is in place, followed and cGMP-compliant Quality decisions are taken, and follow-up is secured. To ensure adequate Health Authority Inspection preparation and successful inspection outcomes.
• Be responsible for monitoring and improving the Quality Management System in accordance with its Quality Manual.
• Establish the application procedures of GMPs through specific plant procedures to ensure a homogeneous and consistent application in line with regulatory requirements and the expectations of the authorities.
• Ensure that the Company Quality Management System is understood, implemented, maintained updated, monitored and maintained efficient.
• Ensure that the objectives set in the Quality Policy are pursued.
• It represents the Management in relations with the Certification Bodies, the Notified Bodies, the Competent Authorities.
• Report to the Management on the progress of the Quality Management System and on any need for improvement.
• Manage the quality reviews, in order to inform the Management on the progress of the Quality Management System.
• Enter into all aspects related to the quality of the product, sensitize all the company's functions to quality objectives and ensure that all company management processes are respected.
• Approve the management procedures (QSE9xx) and the Quality Manual.
• Collaborate with the Qualified Person and with the managers of the various functions to issue and update the Site Master File and the Validation Master Plan.
• Approve or refuse and guarantee that batches of drugs are approved or rejected according to the relevant regulations.
• Manage the drafting and approval of the Product Quality Review.
• Establish a system for the preparation, evaluation and approval of all procedures that affect the quality of raw materials, intermediate products and products.
• Guarantee the conservation of rules, procedures, specifications, archives and all documentation relating to the Quality Management System.
• Guarantee the correct physical management of the Gipharma documentation archive in collaboration with the Operations Director and the Qualified Person.
• Establish a system for the preparation, assessment and approval of changes that could potentially influence the quality of raw materials, intermediate products and products.
• Establish a system for the presentation, evaluation, development of projects.
• Establish a system for verifying production and laboratory control records of product batches before they are approved.
• Establish a system for the approval or rejection of all products before being placed on the market or intended for clinical trials.
• Establish effective identification and traceability systems for critical components.
• Ensure that in-process controls during labeling and secondary packaging of pharmaceutical products and medical devices are performed correctly with the aim of ensuring correct traceability data.
• Establish a system for the basic training of newly recruited personnel and for the periodic training of all personnel, with particular regard to the personnel assigned to the work in controlled contamination premises, including the staff of the external cleaning company
• Coordinate the drafting of the programs of training (planning and review) of all the personnel.
• Establish a system for the correct selection, evaluation and approval of suppliers of critical materials, components and services.
• Establish a system for the proper investigation and resolution of deviations in order to regulate the prevention and control of non-conformity of products, processes and the Quality Management System for the safety of medicines and medical devices.
• Establish a system for the proper investigation and resolution of complaints related to products and devices produced and/or distributed by the company.
• Collaborate with the Competent Authority during the investigation procedure of the notified complaint and its closure.
• Coordinate any corrective and preventive action, undertaken on the basis of the performance of the non-conformities, customer complaints, the results of internal audits and the elements emerged during the review of the Quality Management System, with the aim of eliminating the potential causes of non-compliance.
• Ensure, verify and approve through scheduled and periodic audits that all company management processes, from the design, production, control, registration and distribution phase comply with the requirements of the company quality system.
• Establish a system for the correct management of printed material for secondary Packaging.
• Establish a system for the approval or rejection of raw materials, intermediates, packaging material.
University or academic degree in Chemistry, Biology, Pharmacy or equivalent
Italian - fluently spoken/written
English - fluently spoken/written
10 years in Quality Assurance and Quality Control in a manufacturing environment within the pharmaceutical industry
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