CSV Specialist

25 set - Latina
BSP Pharmaceuticals

ppBSP 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. Posizione: To expand its workforce, BSP Pharmaceuticals is seeking candidates for opportunities within the CSV Data Integrity areabResponsibilities: /b /pulliDrafting and execution of validation documents for laboratory and production computer systems (analytical instrumentation, HMI, SCADA...) /liliValidation Plan /liliSystem Configuration /liliValidation protocols (IQ/OQ/PQ)



/liliTraceability Matrices /liliReports /liliPerforming testing activities of laboratory and production computerized systems. /liliPerforming periodic reviews of computerized systems /liliReviewing vendor documents /liliParticipation in SAT and FAT /liliCollaboration in writing departmental SOPs and the Validation Master Plan for computerized systems /li /ulRequisiti:ulliExperience in Computer System Validation /liliMaster's degree in a scientific disciplines /liliThorough knowledge of 21 CFR Part 11 and Annex 11 regulations and Data Integrity principles. /li /ulAltre informazioni: 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. /p #J-18808-Ljbffr

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