Quality Assurance Position In Tiget Clinical Lab (Sr-Tiget, Milan) Milano

Quality Assurance Position In Tiget Clinical Lab (Sr-Tiget, Milan)
Milano
Lombardia, Milano

IRCCS San Raffaele Scientific Institute in Milan, Italy, is looking for Quality Assurance Officer to join the TIGET Clinical Lab (TCL) (https://research. hsr. it/en/institutes/san-raffaele-telethon-institute-for-gene-therapy/sr-tiget-clinical-lab. html)  coordinated by dr. Matias Soncini at the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget), Milan, Italy.

The Institute.

SR-Tiget was created in 1996 as a joint-venture between Fondazione Telethon and Ospedale San Raffaele (OSR), with the mission to perform cutting edge research on gene and cell therapy and to translate its results into therapeutic advances for genetic diseases.

The Institute is located within the OSR campus, which includes a large multi-disciplinary research hospital, a biomedical research center, a university and also hosts several biotechnologies companies.

Over the years, SR-Tiget has given a pioneering contribution to the gene and cell therapy field with relevant discoveries in vector design, gene transfer and gene editing strategies, stem cell biology, identity and mechanism of action of regulatory cells in immune responses and innate immune cells in cancer.

SR-Tiget has also established the resources and framework for translating these advances into novel experimental therapies and has implemented several successful gene therapy clinical trials, which have already treated>130 patients and led to the filing and approval of 2 novel advanced therapy medicines.

The TCL is one of the Development and Clinical Research units at TIGET.

In particular, it is a clinical research laboratory that performs analyses of samples from patients who have undergone experimental Gene Therapy.

TCL is an AIFA autocertified Phase I laboratory where the biological effects of Gene Therapy are studied following approved Clinical Protocols and in compliance with Good Clinical Laboratory Practice (GCLP) and ISO 9001.

The position.

We are looking for a motivated Quality Assurance officer to join us for a position in TCL, working in collaboration  with other TIGET QAs and under the supervision of the laboratory QM and Coordinator.

Main tasks: Management and maintenance up to date Quality Documentation; Distribution of Quality Documentation to the Staff; Maintenance of staff training documentation; Verify/Writing IOS, Modules or template as for his/her competences; Support for AUDIT/inspection.

Secondary tasks (after seniority): Conducting the Quality Assurance activities: internal audits to ensure compliance with appropriate Standard Operating Procedures and regulations; Provide support to staff in laboratory activities in terms of GCP, GCLP and Determina AIFA compliance; CAPA management and collaboration with Lab Coordinator, Laboratory Study Manager, and Scientific Project Leader to resolve NC or any issue coming out from AUDITs and/or inspections; Organisation of Quality assurance task training; Support on definition, collection, and analysis of Unit indicators; Participate to Analytical and Feasibility Plans.

Qualifications and skills: Scientific Bachelor or Master's Degree with previous wet lab experience; Knowledge of Quality Systems gained by experience or training; Experiences in ISO (9001-15189), GLP, GCP or IVDR are a plus and will be considered for a senior position; Effective communication; Analytical and problem-solving skills; Friendly, collaborative, pro-active mindset; Good oral and written English.

We offer: Salary depending on qualifications and experience; A dynamic environment and the chance to give important contribution to clinical translation of innovative ATMP; Place of work: IRCCS San Raffaele Hospital, Via Olgettina, number 60 - Milan (Italy).