Quality Assurance Specialist

2 settimane fa

Modena, Italia Evotec Wd A tempo pieno

Quality Assurance Specialist page is loaded Quality Assurance Specialist Apply locations Modena time type Full time posted on Posted 4 Days Ago job requisition id JOB ID-10420 Evotec is a leader in the discovery and development of novel small molecule drugs with operational sites in Europe and the US. The Company has built substantial drug discovery and development expertise and an industrialized platform that can drive new innovative small molecule compounds into the clinic. In addition, Evotec is building an integrated platform to deliver iPSC-based therapeutics to patients and an innovative off-the-shelf cell therapy project portfolio. Leveraging these skills and expertise the Company intends to develop best-in-class differentiated therapeutics and deliver superior science-driven discovery and development alliances with pharmaceutical and biotechnology companies.
For our cell therapy manufacturing site in Modena, we are looking for a highly motivated GMP Quality Assurance, possibly experienced in aseptic manufacturing . This position will have a key role in Cell and Gene therapy team to guarantee company and intercompany ATMP manufacturing activities .
Essential Functions manage a comprehensive documentation system for all Cell Factory operationscollaborating in risk analysiscollaborating in change management systemmanaging deviations and corrective/preventive actionsregularly inspect all departments and assess their GMP compliance statussupport the development of appropriate training plans for new and existing staffqualify external suppliershandling complaintsdistributing production batch recordsexecute the Batch Record ReviewDocument management Required Skills & Abilities Knowledge of current GxP guidelinesPositive, team player and problem-solving attitudeAccurate, with excellent prioritization and organization skillsCommitment to the assigned deadlines and ability to deliver them tightlyEnglish intermediate level is required (written and spoken)Good knowledge of Microsoft Office applications Education BS or MS Scientific Degree (e.g. Biotechnology, Biology, Pharmacy, CTF…) Experience Previous experience in Quality Assurance is mandatory (3+ years)Previous experience with ATMPs is a plusPrevious experience with sterile productsPrevious experience in environmental monitoring, safety methods and mediafill activities FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

About UsEvotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company's multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this "Data-driven R&D Autobahn to Cures" for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company's 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn .
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