Quality Assurance Specialist Siena

Quality Assurance Specialist
Siena
Toscana, Siena

Social network you want to login/join with:Quality Assurance Specialist, Province of ModenaClient:Location:Province of Modena, ItalyJob Category:OtherEU work permit required:YesJob Reference:08b94065fec2Job Views:16Posted:06. 03. 2025Expiry Date:20. 04. 2025Job Description: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 Specialist, possibly experienced in aseptic manufacturing.

This position will have a key role in the 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. Collaborate in risk analysis. Manage 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. Distribute 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 media fill activities. ENG: In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

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