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1 settimana fa

Rome, Italia BSP Pharmaceuticals S.p.A. A tempo pieno

BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry. BSP has been at the forefront in the fight agains 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 Organization (CDMOs) for anticancer drugs.The fight against cancer is ours too.The resource will be part of the Material Quality team, as Supervisor and focusing on the following activities:Supervise and monitor department activities, supporting the manager in charge Supervise and manage material master data management activities, issue analytical specifications and stability studies (through the LIMS system) in compliance with current procedures and national and international regulations. Supervision and management of activities related to secondary packaging: PCK change control, information on variable data related to presentations on authorized markets, artwork approval, Good To Print management, management of secondary packaging production recipes using dedicated software (SNI Vault & Printer). Supervision and management of customer relations for the approval of analytical specifications and artwork. Supervision and management of supplier relations for the management of activities related to material records. Management of analytical reduction programs for raw material specifications (excipients, reagents, and primary packaging). Verify compliance with the requirements for Under Test authorization for raw materials and Conditional Release for semi-finished products Support the Manager in drafting the Management Review Collaborate with the Manager, QP, and Quality Operation Manager in preparing and supporting, as SME (Subject Matter Expert), audits and inspections by external bodies, through the direction, coordination, and control of the subordinate structure and the management of GMP documentation under their responsibility Support the review of Quality Agreements with customers Support the Manager in preparing the budget for the area of competenceRequirements :MA degree (CTF/Chemistry..) 5/6 years of experience in similar roles in complex organizations Knowledge of GMP English working knowledge Great can-do attitudeIf you meet the requirements, apply now.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 the diversity , the different backgrounds and experiences and provide equal opportunity for all.We are BSP

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