CSV Specialist

26 ott - Latina
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. /ppBSP has been at the forefront in the fight agains cancer since 2006. /ppInnovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. /ppWe are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs. /ppThe fight against cancer is ours too. /ppTo expand its workforce, BSP Pharmaceuticals is seeking candidates for opportunities within the CSV Data Integrity area /ppbResponsibilities: /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 /liliParticipation in SAT and FAT /liliCollaboration in writing departmental SOPs and the Validation Master Plan for computerized systems /li /ulh3Requisiti /h3ulliExperience 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 /ulpAt 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

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