Quality Control Manager
- Forlì, Italy
AAA Statement Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients' lives by leading innovation in nuclear medicine.
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 Control Manager ensures that quality control processes for materials acceptance, batches quality control and QC equipment validation/qualification are executed and fully compliant to cGMPs regulation, corporate and national guidelines.
• Raw materials, packaging materials, semi-finished products acceptance according to specifications;
• Manage, coordinate and approve the execution of the analytical activities for the batch release;
• Ensure that all quality control processes, equipment and software are validated/calibrated according to the Validation Master Plan;
• Ensure that all methods used in QC analysis are validated according to SOPs, MA and cGMPs;
• Assure the adequacy of the SOPs of Quality Control department
• Perform the APR achievement according to the calendar
• Perform the audit trail review of the quality control equipment software;
• Verify the data integrity of the QC software;
• Maintain, review and approve the records of the QC activities;
• Ensure the existence of a system of procedures to guarantee the quality and efficacy of the QC department;
• Ensure that all QC materials are properly and safely stored, identified, labelled recorded and monitored according to SOPs and specifications;
• Ensure that the stock of materials, reagents, standards is properly available and ordered;
• Ensure, in collaboration with QA department, that out of specifications, out of trend, deviations, CAPA, change controls related to the QC department are addressed and recorded according to cGMP and SOPs;
• Collaborate with other functions for the redaction of the stability programs and the annual product review;
• Ensure the initial and periodic training of QC analysts;
• Manage the presence, shifts and performances of the QC analysist;
• Collaborate with QA department for the period self-inspections and external audits (Health Authorities, Certified Bodies, Supplier);
• Guarantee the cleanliness and tidiness and application of Good Laboratory Practice
• Ensure the complete independence of the QC activities from the Production department.
Education: Scientific degree
Languages: English fluently, verbally and in writing
• 2+ years of experience in QC dept.
• Excellent organizational skills (time management, risk management) including attention to detail and multitasking skills
• Open and clear collaboration and communication to make sure the daily operation runs smoothly
• Shows the appropriate sense of urgency around given tasks
• Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system
• Preferred qualification to Qualified Person
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