Quality System Specialist LATINA

Quality System Specialist
Latina
Lazio, LATINA

BSP Pharmaceuticals S. p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the Pharmaceuticals Industry. BSP has been at the forefront in the fight against cancer since 2006. Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. We are one of the most important Contract Development and Manufacturing Organizations (CDMOs) for anticancer drugs. The fight against cancer is ours too. We are currently looking for a Quality System Specialist that will mainly ensure: Main Activities: Vendor Qualification Area Update the supplier qualification plan, external GMP impact laboratories and services, perform supplier audits with specific tests and analyses, in compliance with current regulations (laws, European and international GMP standards etc. ); Manage change notifications received from suppliers, quality events associated with suppliers of materials, service providers and GMP-impacted external laboratories. Contamination Control Strategy (CCS) Area Draft, issue and maintain the Contamination Control Strategy Document (CCSD), review documentation associated with CCS, manage and collect CCS metrics data, draft periodic reports, support the Contamination Control Strategy Expert figure in reviewing all plant GMP changes for CCS impact assessment and prepare CCS Quality Questionnaires received from Clients. Internal/External Audit Area Support the Manager in the management of internal audits and audits required by customers, in compliance with company quality policies and procedures; Prepare and support regulatory inspections, through the collection and provision of all information necessary for the audit, in order to enable the smooth conduct of GMP-regulated activities, in compliance with applicable regulations (laws, European and international GMP standards etc. ). Quality Risk Management Area Implement and maintain the register of risk assessments carried out in each plant area to ensure their effective validity over time. Annual Product Quality Review Area Perform the Annual Product Review and all related activities, trend analysis to support the Management Review in accordance with applicable regulations (laws, European and international GMP standards etc. ). Main Requirements: Master's Degree in Chemistry, CTF, Biology, Pharmacy, etc. ; Advanced knowledge of English; Knowledge of European and international GMP; Strong analytical skills, business-oriented, client-oriented; Great can-do attitude. At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect diversity, different backgrounds and experiences, and provide equal opportunity for all. We are BSP. J-18808-Ljbffr