Quality Specialist, Quality Assurance

1 settimana fa

Modena, Italia Evotec A tempo pieno

Evotec 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 4,200 highly qualified people. The Company’s 16 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to

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We have an interesting opportunity at Evotec Modena, Medolla (MO) for a 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

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)

Education
- BS or MS Scientific Degree (e.g. Biotechnology, Biology, Pharmacy, CTF )

Experience
- Previous experience in Quality Assurance is mandatory (2+ years)
- Previous experience with ATMPs is a plus
- Previous experience with sterile products is a plus

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