Quality Assurance Specialist

6 mesi fa

Modena, Italia Evotec Modena Srl A tempo pieno

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 operations collaborating in risk analysis collaborating in change management system managing deviations and corrective/preventive actions regularly inspect all departments and assess their GMP compliance status support the development of appropriate training plans for new and existing staff qualify external suppliers handling complaints distributing production batch records execute the Batch Record Review Document management

Required Skills & Abilities

Knowledge of current GxP guidelines Positive, team player and problem-solving attitude Accurate, with excellent prioritization and organization skills Commitment to the assigned deadlines and ability to deliver them tightly English 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 plus Previous experience with sterile products Previous 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.

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