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qc data reviewer
1 settimana fa
Funzione: Document Controller
Categoria: Segreteria - Servizi Generali
Inizio previsto: 01/07/2024
Luogo di lavoro: Monza, Monza E Della Brianza
ADECCO ricerca per importante realta' multinazionale del settore chimico farmaceutico un/a:
REVISORE SETTORE PHARMA.
La risorsa, che entrera' a far parte del Dipartimento di Sviluppo Analitico di nuovi prodotti non ancora in commercio, deve essere esperto nell'uso e nella valutazione di tutti i dati analitici ottenuti dalle strumentazioni utilizzate per l'analisi di piccole e grandi molecole, come l'HPLC, GC, IR, UV-Spettrofotometro e altre apparecchiature minori. Sara' responsabile della revisione dei dati analitici per l'analisi delle materie prime, in particolare API, del prodotto in process, dei prodotti finiti e delle formulazioni, utilizzando autonomamente l'HPLC e UPLC, FT-IR, Spettrofotometro UV, Viscosimetro, rispettando i metodi analitici e le procedure operative standard (SOP).
La figura che verra' scelta:
- si occupera' della revisione di attivita' quali lo sviluppo dei metodi analitici, il trasferimento, la validazione dei metodi analitici, le analisi di routine e le analisi di stabilita'
- compilera' i dati per la documentazione delle procedure di prova e preparera' i report
- garantira' che tutti i processi di test, il monitoraggio e la documentazione del dipartimento soddisfino gli standard normativi SOP e GMP
- segnalera' immediatamente i risultati inaspettati o fuori specifica (OOS), eventuali anomalie, al Sipervisor
- condurra' indagini di laboratorio e le documentera'
- interagira' con i clienti interni ed esterni per impostare le tempistiche, comprendere le richieste di lavoro, definire e risolvere i problemi, assegnare e distribuire il lavoro e comunicare i risultati
- esaminera' la documentazione di laboratorio per il calcolo, l'inserimento e la conformita' alle GMP
- fara' attivita' di verifica e valutazione della documentazione analitica rilasciata dal laboratorio per garantire l'integrita' dei dati, attraverso la corretta programmazione delle attivita' quotidiane, il controllo dell'andamento delle attivita', nel rispetto delle priorita' definite dal proprio responsabile e dagli standard di qualita' aziendali
Si richiede:
- Laurea in Chimica Farmaceutica, Biologia, Chimica, Biotecnologie o similari
- Esperienza di almeno due/tre anni in laboratorio chimico analitico
- Ottima conoscenza delle GMP, delle tecniche analitiche e della relativa strumentazione: HPLC, FT-IR, UV-VIS, prove fisiche
- Ottima con
Esperienze lavorative:
tecnico analista chimico - 12 mesi
Titolo di studio:
Laurea Magistrale - Chimico - Biologico - Ambientale - Chimica e tecnologia farmaceutiche
Lingue conosciute:
Inglese: Comprensione Ottimo
Competenze:
Word Processor - Elaborazione testi - Word, livello Ottimo
Fogli di calcolo - elettronici - Excel, livello Ottimo
Progettazione - Disegno tecnico - Microsoft Office, livello Ottimo
Chimica - Analisi strumentali
Chimica - Preparazione reagenti chimici
Information Technology Altro - Formule di Excel, livello Ottimo
Information Technology Altro - Tabelle Pivot Excel, livello Ottimo
Disponibilita' oraria: Full Time
CCNL: Chimica - Farmaceutica Industria
Livello contratto: D1 Livello D1
Benefits: Mensa aziendale
Patente: B
Mezzo di trasporto: Auto, Riferimento: Titolo di studio minimo: Comune e/o quartiere: Monza, Monza E Della Brianza
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