REGULATORY AND BLOOD BANK ANALYST

Regulatory And Blood Bank Analyst - Working atOctapharma means to have an opportunity to contribute to our common goal- developing lifesaving therapies to improve patients- lives. LOCATION:Brazil, São PauloPOSITION:Regulatory and Blood Banks AnalystYOUR ROLE:A highly motivated and experienced professional to join and lead the Regulatoryand Blood Banks Management team in Brazil. This position will also assume 3 main role positions, namely, Qualification ofBlood Centers including its monitorization, serve as liaison for the plasmacollection supporting in the logistics coordination and finally assist theRegulatory Department at Octapharma Brazil. Your main responsibilities and opportunitiesRELATIONSHIP WITH HEMORREDE (BLOOD CENTERS NETWORK):QUALIFICATION OF BLOOD CENTERS:Organization of documentation of qualifying blood centers, as well as collectionof missing documents and monitoring the documents expirationKeep process indicators up to dateMonitoring of the audit plan and communication with the corresponding auditservice providerAudit reports translationCharacterization of the Hemorrede regarding infrastructure and valence; tabulationof the information contained in the questionnaires prior to the audits; Completion of the form and other diligence leading to the qualification ofservicesQAA - implementation and signature of the Quality Agreement and its annexesAudit findings monitoring and verification of submission of evidence according tothe deadline established in the CAPAParticipation in meetings between national and international teamsPLASMA COLLECTION LOGISTICS:Relationship with the serviceprovidersSupport in the organization and scheduling of plasma collections at Blood banksControl of necessary inputs for plasma collectionOrganization the collection documentation and upload of records in correspondentplatformsMonitoring and plasma documentation checkingManagement of previous monthly amounts of collection in each blood centerHEMORREDE MANAGEMENT AND MONITORING:PERIODIC TECHNICAL VISITS TO BLOOD CENTERS:Developed processes monitoring, verification of needs and improvementsActions proposals that make possible to increase the number of bags collectedmonthlyREGULATORY:Preparation and submission of the Brazilian Plasma Master FileMaintenance of regulatory documentation inherent to the qualification of bloodcenters (see 1. A)Identify new regulatory legislation and its updates related to the HemotherapyareaYOUR EXPERTISE:1/3 years in similar functionPharmaceuticals degreeEnglish - excellent written and oral skills. Good grasp of pharmaceutical and biotechnological concepts; Solid knowledge of Regulatory Affairs of biological drugs; Good command of eCTDGMP and GDP regulationHighly motivated, Analytical; Independent; MethodicTeam-workerSelf-starter; effective in a highly dynamic environment where priorities canchange rapidlyWhat we offerDevelop and grow a professional career in an exciting, challenging andinternational environment. You will have a high level of influence where you can make a difference and leaveyour footprint. Be rewarded with an attractive salary and benefits package. Work with skilled and fun colleagues. How to applyPLEASE APPLY ONLINE IN ENGLISH DESCRIBING YOUR INTEREST, AND ENCLOSING YOUR CV, REFERENCES AND/OR RECOMMENDATION LETTERS TO: