Gcp Quality Assurance Manager o di Un Gcp Quality

6 giorni fa


Milano, Italia Società Italiana di Medicina Farmaceutica A tempo pieno

LB Research (CRO con sede a Cantù) ricerca di un GCP Quality Assurance Manager o di un GCP Quality Assurance.

Possibilità di una posizione con contratto a tempo indeterminato e possibilità di svolgere parte del lavoro in Smart Working.

Profilo QA

Requisiti richiesti QA:

- Almeno 2/3 anni di esperienza nel ruolo
- Laurea magistrale
- Formazione in accordo al DM 15/11/2011

Mansioni da ricoprire:

- Revisione dei QMS Change Control Plans.
- Revisione/ approvazione delle SOPs e altri documenti del QMS. - Qualifica/ Riqualifica di Service Providers.
- Organizzazione trainings per lo Staff interno ed esterno.
- Revisione Quality Agreement con GxP Service Providers.
- Preparazione/ revisione dei documenti necessari per Audits.
- Valutazione non-conformità e valutazione adeguatezza CAPA Plans,
- Supervisione dell’implementazione dei CAPA Plans.
- Prendere parte al Risk Assessment Team.
- Quality control dei documenti studio specifici.
- Conduzione e reportistica di GCP computerized system Periodic Reviews.
- Supporto allo Staff in relazione a quality issues.
- Mantenimento dell’Archivio.

Profilo QAM

Requisiti richiesti QAM:

- Almeno 5 anni di esperienza nel ruolo
- Laurea magistrale
- Formazione in accordo al DM 15/11/2011
- Requisito plus: Auditor ISO 9001: 2015

Mansioni da ricoprire:

- Collegamento primario con la Direzione, Sponsor/Cliente e risorse interne ed esterne (personale LB e fornitori di servizi) per questioni di qualità.
- Revisione dei QMS Change Control Plans e supervision della relativa implementazione.
- Pianificazione della revision delle SOPs e Quality Manual.
- Revisione/ approvazione delle SOPs e altri documenti del QMS.
- Riaqualifica dello Staff interno e dei Service Providers.
- Pianificazione, verifica e reporting della formazione del personale.
- Preprazione/ revision del Quality Agreement con GxP Service Providers.
- Programmazione, pianificazione e coordinamento degli audits promossi da LB.
- Coordinamento delle attività di audits del QMS promossi dallo Sponsor/Cliente e delle ispezioni del QMS da parte delle Autorità Regolatorie.
- Mantenimento del registro delle non conformità, valutazione delle non conformità spontanee ricevute, valutazione dell'adeguatezza dei CAPA proposti, supervisione dell'attuazione dei CAPA concordati.
- Prendere parte al Risk Assessment Team.
- Prendere parte all’Emergency Management Team incaricato dell’attuazione del Business Continuity Plan.
- Quality control dei documenti studio specifici.
- Pianificazione, conduzione e reportistica di GCP computerized system Periodic Reviews.
- Supporto allo Staff in relazione a quality issues.

Richieste

Questo servizio è fornito gratuitamente da SIMeF a tutti.



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