COMPANY DESCRIPTION

GenIbet 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:
o Qualification of Suppliers of: Materials (RM,PKs, DI), Services, Contracted Analysis Laboratories
o Generation, revision and updating of documentation related to external audits and supplier qualification processes: Technical Agreements, Pre-audit Questionnaires, Audit Reports, etc
o Generation, implementation, and follow-up of the Internal Audit plan
o Follow-up of CAPAs generated in the process of Internal, External and Regulatory Entities Audits
o Handling of Supplier Complaints
o Handling of Supplier Notifications
o Back-up of Incidents and Deviations, Change Controls and CAPAs. Evaluation and follow-up of Change Controls related to Suppliers and Audits
o Implementation, reporting and monitoring of KPIs
o Generation and review of SOPs. Implementation and monitoring of SOPs related to supplier qualification, internal walk-throughs (self-inspections) and supplier claims
o Ensure quality assurance organization and operating procedures are in place to support assigned programs of work

REQUIREMENTS:
o BSc or MSc in Chemical,  Biological Engineering,  Pharmaceutical Sciences or other relevant area
o More than 2 years of professional experience in supplier and services management or Quality Assurance in pharmaceutical sector
o Fluent English (spoken and written)

OFFERED:
o Competitive salary and attractive benefits
o Opportunities for professional growth and development
o Innovative and collaborative working environment
o Participation in challenging projects with a global impact.

HOW TO APPLY
Send your CV to: recruitment@genibet.com

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!