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 Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
o Oversee and support the life-cycle management of validated software systems incl. change management, periodic review, and system retirement.
o Support in 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 with equipment’s, 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
o Facilitator between different departments: Production, QC and Maintenance
REQUIREMENTS: o BSc or MSc in Chemical, Biological, Mechanical or Industrial engineering or other relevant area
o 2 years experience in Pharmaceutical Industry
o GMP knowledge
o Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
o Fluent in English
o Team player
o Problem resolution and critical thinking skills

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!