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Quality system specialist

Latina
BSP Pharmaceuticals S.p.A.
Pubblicato il 11 settembre
Descrizione

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. /ppbr/ppstrongThe fight against cancer is ours too. /strong /ppbr/ppstrongWe are currently looking for a emQuality System Specialist /emthat will mainly ensure : /strong /ppbr/ppstrongContamination Control Strategy (CCS) /strong /ppDraft, issue and maintain the Contamination Control Strategy Document (CCSD, review documentation associated with CCS, manage and collect CCS metrics data, draft periodic reports, support the Contamination Control Strategy Expert figure in reviewing all plant GMP changes for CCS impact assessment and prepare CCS Quality Questionnaires received from Clients. /ppbr/ppstrongInternal/External Audit Area /strong /ppSupport the Manager in the management of internal audits and audits required by customers, in compliance with company quality policies and procedures; /ppPrepare and support of regulatory inspections, through the collection and provision of all information necessary for the audit, in order to enable the smooth conduct of GMP-regulated activities, in compliance with applicable regulations (laws, European and international GMP standards etc.). /ppbr/ppstrongQuality Risk Management Area /strong /ppImplement and maintain the register of risk assessments carried out in each plant area to ensure their effective validity over time. /ppbr/ppstrongAnnual Product Quality Review Area /strong /ppPerform the Annual Product Review and all related activities, trend analysis to support the Management Review in accordance with applicable regulations (laws, European and international GMP standards etc.). /ppbr/ppstrongMain Requirements: /strong /pulliMaster's Degree in Chemistry, CTF, Biology, Pharmacy ecc; /liliAt last 3 years of experience in similar roles in complex organizations /liliAdvanced knowledge of English; /liliStrong analytical skills, business-oriented, client-oriented; /liliGreat can-do attitude. /li /ulpbr/ppIf you meet the requirements, apply now. It could be your next step. /ppbr/ppemAt 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. /em /ppbr/ppemWe are BSP. /em /p

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