Requirements: English
Company: BSP Pharmaceuticals S.p.A.
Region: Latina , Lazio
BSP Pharmaceuticals S.p. A is focused on thedevelopment and manufacturing of anticancer drugs with high potencyand cytotoxitc characteristics for the Pharmaceuticals Industry.BSP has been at the forefront in the fight agains cancer since2006. Innovation is the hallmark of BSP with investments in newtechnologies and production methods in a high containment plant. Weare one of the most important Contract Development andManufacturing Organization (CDMOs) for anticancer drugs. The fightagainst cancer is ours too. We are currently looking for a QACompliance Specialist - that will mainly ensure: Main activites:Deviations and Investigations Management: - Carry outinvestigations related to deviations from the production processwith the aim of identifying their Root Cause through documentverification and close cooperation with other departments incompliance with SOPs, current regulations and company qualitystandards; - With the support of the other departments, proposecorrective and preventive actions in order to ensure effectiveclosure of deviations in compliance with quality standards andcompany procedures; Complaint Management: - Carry outinvestigations related to complaints from customers throughunderstanding the causes and identifying the most appropriatecorrective or preventive actions collaborating with otherdepartments in order to maximize customer satisfaction, incompliance with SOPs, current regulations and specific agreementssigned with customers; Audit Support: - Support the manager in thepreparation and management of client and regulatory Audits. BRR: -Ensure compliance and completeness of the Batch Record, throughcollection and analysis of all necessary documentation; -Documentary verification of material approval status, of check listand current SOPs, in compliance with applicable regulations (laws,GMP regulations, FDA, etc.) and company quality standards. MainRequirements: - Master''s Degree in Chemistry, Chemistry andPharmaceutical Technology, Biology, Pharmacy; - Professionalknowledge of English; - At least 2 years of experience in the samerole in pharmaceutical organizations; - Good knowledge of SterilityAssurance; - Good knowledge of GMP. If you meet the requirements,apply now. At BSP we believe in an inclusive workplace thatcultivates bold innovation through collaboration, and empowers ourpeople to unleash their full potential. We respect the diversity ,the different backgrounds and experiences and provide equalopportunity for all. We are BSP