Shire QO Coordinator in Pisa (Baxalta), Italy

Eseguire attività di routine relative al programma di monitoraggio delle aree classificate, degli impianti di acqua farmaceutiche, aria compressa

Eseguire ed Inserire i risultati del test AQL per lo step di visual inspection sul sistema SQL*LIMS, in accord alle procedure locali

Eseguire la batch record review in accordo alle procedure locali

Verifica applicazione GMP in produzione: effettuare ispezioni on the floor in accordo SOP locale,e identificare opportunità di miglioramento , ed implementatre un adeguato piano di azioni correttive per incrementarela compliance GMP i produzione

Eseguire investigazioni nell’ambito di deviazioni e CAPA

Eseguire e gestire l’analisi del trend dei parametri microrbiologi e particellari ambientali supporttao dai tool statistici in vigore, in accordo alle procedure locali e di Shire.

Revisione e gestione documentazione di reparto

Discreta conoscenza lingua inglese

Conoscenza pacchetto Office

E’ preferita la conoscenza base del sistema SQL*LIMS

E’ preferita pregressa esperienza in ambito farmaceutico

E' richiesta laurea in discipline scientifiche

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.