CSV Specialist

26 ott - Italia
BSP Pharmaceuticals

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 pThe fight against cancer is ours too. /p h3Posizione: /h3 pTo expand its workforce, BSP Pharmaceuticals is seeking candidates for opportunities within the CSV Data Integrity area /p h3Responsibilities /h3 ul liDrafting and execution of validation documents for laboratory and production computer systems (analytical instrumentation, HMI, SCADA...) /li liValidation Plan /li liSystem Configuration /li liValidation protocols (IQ/OQ/PQ)



/li liTraceability Matrices /li liReports /li liPerforming testing activities of laboratory and production computerized systems. /li liPerforming periodic reviews of computerized systems /li liReviewing vendor documents /li liParticipation in SAT and FAT /li liCollaboration in writing departmental SOPs and the Validation Master Plan for computerized systems /li /ul h3Requisiti /h3 ul liExperience in Computer System Validation /li liMaster's degree in a scientific disciplines /li liThorough knowledge of 21 CFR Part 11 and Annex 11 regulations and Data Integrity principles. /li /ul h3Altre informazioni /h3 pAt BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. /p pWe respect the diversity , the different backgrounds and experiences and provide equal opportunity for all. /p pWe are BSP. /p #J-18808-Ljbffr

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