Quality System Specialist

BSP Pharmaceuticals S.p.A is a Contract Development and Manufacturing Organization (CDMO).The BSP campus hosts 2 segregated facilities to serve the clients with development from pre-clinical GLP to cGMP manufacturing for clinical and commercial supply of Cytotoxic and High Potent Oncology drugs and Non-Cytotoxic, innovative compounds for Immunotherapy and other therapeutics applications.Facilities designed to handle small and large molecules as ADCs (conjugation and fill finish), Peptides, Proteins, Oligonucleotides and Nano Medicines.BSP is technologically developed to meet the needs of innovators, with its High Containment Facility designed to offer a full range of integrated services aimed to support the entire life cycle of a product, from the formulation and process development/optimization, through scale up/scale down studies

Posizione:

Area Contamination Control Strategy (CCS)

Assicurare l’esecuzione delle attività relativa alla Contamination Control Strategy in accordo alle SOP di stabilimento.

In particolare la risorsa si occuperà della stesura, emissione e mantenimento del Documento di Contamination Control Strategy (CCSD, revisione della documentazione associata alla CCS, gestione e raccolta dati metriche CCS, stesura report periodici, supporta la figura di Contamination Control Strategy Expert nella revisione di tutti i cambi GMP si stabilimento per valutazione impatto in ambito CCS e nella preparazione di Questionari Quality in ambito CCS ricevuti dai Clienti.

Requisiti:

Essenziali

Laurea in discipline scientifiche (Chimica, CTF, Farmacia, Biologia)

Conoscenza GMP europee ed internazionali

Ottima conoscenza lingua inglese

Esperienze professionali in ambito Quality in aziende farmaceutiche

Altre informazioni:

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.We are BSP.