QUALIFICATION AND VALIDATION – TECHNICIAN
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• • • • Recipharm | QUALIFICATION AND VALIDATION – TECHNICIAN • • QUALIFICATION AND VALIDATION – TECHNICIAN Lisbon Mail a friend Share Share Tweet POSITION NAME: QUALIFICATION AND VALIDATION – ASSISTANT 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 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 • 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 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 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! Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 4,500 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden. For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com URL to this pagehttps://www.recipharm.com/careers/job-search/apply?rmpage=job&rmjob=3556&rmlang=UK