Quality Assurance Specialist

5 mesi fa


Arese, Italia S&You A tempo pieno

**S&you divisione Pharma, **brand internazionale dedicato al Professional Staffing e Ricerca e Selezione di personale qualificato e middle management, nel settore farmaceutico e biomedicale, seleziona un/una Quality Assurance Specialist, per nota azienda farmaceutica.

**Posizione**:
La risorsa verrà inserita all’interno della Quality Unit e riporterà al Responsabile della Quality Assurance.

In particolare, la risorsa si occuperà delle seguenti attività:

- Redazione di documentazione e reportistica QA - Product quality review; reportistica di Cleaning Validation; Convalide di processo; supporto alla qualifica degli impianti per aspetti di ambito QA, etc.
- Raccolta e tabulazione di dati, a necessità - KPI/quality metrics mensili e reportistica annuale
- Supporto nella redazione di procedure ed implementazione di istruzioni operative
- Verifica compliance APIs assegnati per garantirne il corretto rilascio Verifica batch records di produzione ed analitici
- Gestione cambi, investigazioni, deviazioni od OOS relativi agli API assegnati
- Supporto in eventuali reclami di prodotto
- Redazione protocolli/rapporti di convalida
- Contatti con il cliente per gli aspetti QA
- Pianificazione ed esecuzione del training al personale di sito
- Esecuzione di Audit interni
- Continua collaborazione e coordinamento con funzioni interne al sito e in ambito Corporate

**Requisiti**:
Requisiti:

- Laurea scientifica con preferenza per indirizzi di Chimica e Tecnologie Farmaceutiche, Chimica, Farmacia
- Esperienza di almeno 2 anni nel ruolo
- Buona conoscenza della lingua inglese (B2)
- Buona conoscenza del pacchetto office - l’utilizzo di tools informatici come SAP costituiranno un plus
- Predisposizione al lavoro in team
- Precisione e puntualità

**Altre informazioni**:

- Le persone interessate sono invitate a leggere l'_informativa privacy_ ex artt. 13 e 14 del Reg. UE 2016/679._
- Aut. Min. Prot. N. 1207 - SG del 16/12/2004_



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