Pds Analytical Development Reviewer
2 settimane fa
ADECCO ricerca per nuovo Dipartimento Farmaceutico di Sviluppo Analitico PDS AD & GMP di importante realtà multinazionale del settore chimico farmaceutico un/a:
PDS ANALYTICAL DEVELOPMENT REVIEWER.
La figura ricercata sarà responsabile della revisione dei dati analitici per l’analisi delle materie prime (in particolare (API), del prodotto in-process e del prodotto finito e delle formulazioni, secondo le procedure operative standard (SOP). Si occuperà della revisione di attività quali lo sviluppo di metodi analitici, il trasferimento e la validazione di metodi analitici, l’analisi di routine e di stabilità. Compilerà i dati per la documentazione delle procedure di prova, preparerà i report. Garantirà che tutti i processi di test, il monitoraggio e la documentazione dipartimentale soddisfino gli standard normativi SOP e GMP. Contribuirà allo sviluppo di nuove tecniche e procedure standard. Verrà coinvolto con Assists nella preparazione di CoA. Documenterà tutti i dati sperimentali in conformità con ALCOA (Attributable, Ligible, Contemporaneous, Original and Accurate). Effettuerà autonomamente la revisione delle analisi ottenute utilizzando apparecchiature quali HPLC e UPLC, FT-IR, Spettrofotometro UV, Viscosimetro seguendo le procedure Analitycal Methods & Standard Operating Procedures (SOPs). Eseguirà la risoluzione dei problemi di base per superare gli errori di idoneità del sistema. Riconoscerà e segnalerà immediatamente al supervisore i risultati inaspettati o fuori specifica (OOS) e condurrà indagini di laboratorio. Preparerà autonomamente report con Empower per i clienti e documenti scientifici, come metodi analitici, protocolli, report, SOP. Gestirà lo sviluppo, il trasferimento e la validazione di campioni in lavorazione, prodotti finiti e campioni di stabilità. Interagirà con clienti interni ed esterni per definire le tempistiche, comprendere le richieste di lavoro, definire e risolvere i problemi, assegnare e distribuire il lavoro e comunicare i risultati. Sovrintenderà alla documentazione della sperimentazione di laboratorio in protocolli e relazioni tecniche. Verificherà la documentazione analitica rilasciata dal laboratorio, per garantire l’integrità dei dati, attraverso la corretta programmazione delle attività quotidiane, il controllo dell’andamento delle attività, nel rispetto delle priorità definite dal proprio responsabile e dagli standard di qualità aziendali.
Si richiede la conoscenza di HPLC, GC,
Data inizio prevista: 04/03/2024
Categoria Professionale: Operai Specializzati
Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
Città: Monza (Monza E Della Brianza)
Esperienza lavorativa:
- tecnico analista chimico - 24 mesi
Istruzione:
- Laurea Magistrale - Chimico / Biologico / Ambientale - Chimica e tecnologia farmaceutiche
Conoscenze linguistiche:
- Inglese - Livello Ottimo
Disponibilità oraria:
- Full Time
- Disp. Turni senza notte
CCNL: Chimica - Farmaceutica Industria
Livello: D1 Livello D1
Retribuzione: 30000
Benefit previsti: Mensa aziendale
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