Supplier/Vendor Qualification Technician

SUPPLIER/VENDOR QUALIFICATION TECHNICIANGenIbet is a cGMP biopharmaceutical CDMO - Contract Development Manufacturing Organization - offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies.GenIbet's core activity is the manufacture and supply of materials for use in early-stage drug development, pre-clinical studies and cGMP manufacturing for clinical trials and commercial.RESPONSABILITIES:Qualification of Suppliers of: Materials (RM,PKs, DI), Services, Contracted Analysis LaboratoriesGeneration, revision and updating of documentation related to external audits and supplier qualification processes: Technical Agreements, Pre-audit Questionnaires, Audit Reports, etcGeneration, implementation, and follow-up of the Internal Audit planFollow-up of CAPAs generated in the process of Internal, External and Regulatory Entities AuditsHandling of Supplier ComplaintsHandling of Supplier NotificationsBack-up of Incidents and Deviations, Change Controls and CAPAs. Evaluation and follow-up of Change Controls related to Suppliers and AuditsImplementation, reporting and monitoring of KPIsGeneration and review of SOPs. Implementation and monitoring of SOPs related to supplier qualification, internal walk-throughs (self-inspections) and supplier claimsEnsure quality assurance organization and operating procedures are in place to support assigned programs of workREQUIREMENTS:BSc or MSc in Chemical, Biological Engineering, Pharmaceutical Sciences or other relevant areaMore than 2 years of professional experience in supplier and services management or Quality Assurance in pharmaceutical sectorFluent English (spoken and written)OFFERED:Competitive salary and attractive benefitsOpportunities for professional growth and developmentInnovative and collaborative working environmentParticipation in challenging projects with a global impact.Be part of a team that is changing the future in the field of Biologics with innovation, passion and excellence. We look forward to receiving your application!
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