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POSITION NAME: |
QUALIFICATION AND VALIDATION – ASSISTANT
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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. |
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RESPONSABILITIES:
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o Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation protocols) o Support the qualification of equipment’s and computerized systems o Operational handling of management of Deviations, CAPAs and Change Control activities o Creation and revision of procedures related to equipment, facilities and computerized systems o Update of the asset management software o Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines
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REQUIREMENTS: |
o BSc or MSc in Chemical, Biological, Mechanical or Industrial engineering or other relevant area o 3 years of experience in the Pharmaceutical Industry o Knowledge of industry regulations and standards (FDA, EMA, GAMP 5, ISPE) o Experience with the qualification of equipment, systems and utilities (HVAC, WFI) o Fluent in English o Passion for hands-on, on-field work o Team player o Problem-solving and critical thinking skills |
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OFFERED:
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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. |
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HOW TO APPLY: |
Send your CV to [email protected] |
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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!