- Processo di R&I : eseguire le attività in conformità con le procedure globali/locali e le norme cGMP.
- Verifica della documentazione tecnica
- Approvazione all'utilizzo di materiali e materie prime: sulla base delle verifiche eseguite, procede con la fase di approvazione all'utilizzo le
- Elaborazione KPIs (Key Performance Indicators) : elabora gli indicatori relativi al processo di rilascio dei materiali.
- Batch Record Review : supporta le attività richieste per la fase di revisione dei batch record , seguendo le procedure locali e rispettando le tempistiche previste.
- Spedizione lotti : esegue le verifiche propedeutiche per la spedizione dei lotti
- Procedure di reparto : contribuisce alla stesura o revisione delle procedure di reparto (SOP, Work Instructions) .
- Investigazioni e attività di miglioramento : supporta le indagini a seguito di deviazioni nonché all'implementazione di azioni correttive, preventive o di miglioramento .
- Progetti di Qualità : partecipa a progetti di miglioramento continuo nell'ambito della tua area di competenza.
- Buona conoscenza dei sistemi JDE (ERP system), SQL*LIMS e Trackwise.
- Familiarità con i programmi del personal computer (Microsoft Office: Word, PowerPoint).
- Buona padronanza della lingua inglese sia scritta che parlata.
- Conoscenza delle normative GMP e farmaceutiche.
- Buone capacità di comunicazione.
- Problem solving.
- Abilità nel lavoro di squadra.
- Precisione ed accuratezza nell'esecuzione delle mansioni assegnate.
- Buone capacità analitiche e di problem solving.
- Capacità di identificare problematiche con impatto GMP e valutare azioni correttive e preventive adeguate.
- Laurea in discipline scientifiche
- Richiesta l'esperienza di almeno 2 anni nei reparti Qualità o Manufacturing nell'ambito di aziende farmaceutiche
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QA Receiving - Pisa, Italia - Takeda
Descrizione
Description
Sarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99)
Job Title: QA Receiving & Inspection (Maternity Leave)
Location: Pisa
Il ruolo di QA Receiving & Inspection deve garantire la qualità e la conformità delle attività legate al sistema di R&l (materiali e materie prime). Nel dettaglio le responsabilità:
CORE ELEMENTS RELATED TO THIS ROLE
Il ruolo di QA Receiving & Inspection richiede competenze tecniche riguardanti il processo produttivo, in particolare per i prodotti sterili, gli impianti e le relative attrezzature, nonché per i sistemi correlati e le procedure applicate.
Le responsabilità includono garantire il rispetto delle procedure e degli standard di qualità del plant, nonché eseguire le attività necessarie per il rilascio dei materiali richiesti nelle aree GXP pertinenti, nel rispetto delle scadenze previste.
DIMENSION AND ASPECTS
Le competenze richieste per questo ruolo includono:
Inoltre, il QA Receiving & Inspection deve dimostrare:
Per quanto riguarda la presa di decisioni e l'autonomia:
L'interazione è preferibile, e il QA Receiving & Inspection deve collaborare con i reparti di Produzione, Ingegneria/Manutenzione, Magazzino e Qualità .
Infine, l'innovazione richiede la conoscenza dell' Annex 1 delle cGMP per prodotti sterili e delle regolamentazioni ISO ; .
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
Locations
ITA - PisaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
