Quality Assurance Specialist
Evotec Modena Srl
Modena
26
Discreto
help
thumb_up Mi piace
Azienda: Evotec Modena Srl
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 Functionsmanage 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 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 EducationBS or MS Scientific Degree (e. g.
Biotechnology, Biology, Pharmacy, CTF…) Experience Previous experience in Quality Assurance is mandatory (3+ years) Previous experience with ATM Ps is a plus Previous experience with sterile products Previous experience in environmental monitoring, safety methods and mediafill activitiesFR : 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.
✔ Evotec Modena Srl