pBSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry. /p pBSP has been at the forefront in the fight agains cancer since 2006. /p pInnovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. /p pWe are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs. /p pCome for Science. Stay for Purpose. /p h3We are currently looking for a QA Capital Projects Aseptic Processes Specialist /h3 h3Main activities : /h3 h3Qualification and Validation: /h3 ul liProvide quality oversight from the initial project phases through to regulatory authorization. /li liConduct risk assessments in collaboration with operational departments to evaluate, manage, and control critical processes. /li liPrepare process validation documentation (including the Master File) and cleaning validation documentation required for AIFA (Italian Medicines Agency) submissions and subsequent operational startup. /li liTrain operational personnel on the execution and completion of validation documentation issued by the team. /li liReview project User Requirement Specifications (URS) to ensure that the construction of machinery and facilities aligns with company procedures and standards. /li liReview qualification and validation documentation for equipment and facilities. /li liPrepare validation documentation for simulated filling processes in compliance with company protocols and procedures,



by executing the operational activities defined in the protocols and coordinating/supervising the tasks performed by other company functions. /li liEnsure adherence to company quality standards by applying procedures relevant to the area of responsibility, in compliance with corporate quality policies and procedures, as well as applicable regulations. /li /ul h3Audits: /h3 ul liCollaborate with the department manager to prepare for and support audits and inspections by external bodies, acting as a Subject Matter Expert (SME). /li /ul h3Safety: /h3 ul liRegarding EHS (Environment, Health, and Safety) obligations and responsibilities, please refer to the provisions of Article 20 of Legislative Decree 81/08 (and subsequent amendments) - "Obligations of Workers." /li /ul h3Main requirements: /h3 ul liDegree in a technical or scientific field /li liKnowledge of pharmaceutical processes /li liKnowledge of analytical methods, /li liKnowledge of pharmaceutical legislation, national/international regulations, /li liKnowledge of pharmaceutical production facilities and processes (both sterile and non-sterile) and aseptic techniques /li liFamiliarity with key software tools (Excel, PowerPoint, MS Project) /li liProficiency in english language /li liStrong organizational and interpersonal skills /li liAptitude for teamwork /li /ul pActual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is : /p pTemporary Contract - 30-35k /p pAt 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. /p pWe are BSP /p #J-18808-Ljbffr

📌 QA Capital Projects & Aseptic Processes Specialist (Latina)
🏢 BSP Pharmaceuticals
📍 Latina