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:
Qualification of Suppliers of: Materials (RM,PKs, DI), Services, Contracted Analysis Laboratories
Generation, revision and updating of documentation related to external audits and supplier qualification processes: Technical Agreements, Pre-audit Questionnaires, Audit Reports, etc.
Generation, implementation, and follow-up of the Internal Audit plan
Follow-up of CAPAs generated in the process of Internal, External and Regulatory Entities Audits
Handling of Supplier Complaints
Handling of Supplier Notifications
Back-up of Incidents and Deviations, Change Controls and CAPAs. Evaluation and follow-up of Change Controls related to Suppliers and Audits
Implementation, reporting and monitoring of KPIs
Generation and review of SOPs. Implementation and monitoring of SOPs related to supplier qualification, internal walk-throughs (self-inspections) and supplier claims
Ensure quality assurance organization and operating procedures are in place to support assigned programs of work
REQUIREMENTS:
BSc or MSc in Chemical, Biological Engineering, Pharmaceutical Sciences or other relevant area
More than 2 years of professional experience in supplier and services management or Quality Assurance in pharmaceutical sector
Fluent English (spoken and written)
OFFERED:
Competitive salary and attractive benefits
Opportunities for professional growth and development
Innovative and collaborative working environment
Participation in challenging projects with a global impact.
HOW TO APPLY:
Send your CV to: ******
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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