Quality Assurance Analyst

hace 2 días

Insurgentes, México Novartis A tiempo completo

**Summary**:
~Supporta attività, operazioni e sistemi efficaci di conformità GxP e/o audit per garantire la conformità delle aree aziendali al Manuale e alle politiche di qualità di Novartis e a tutti i pertinenti requisiti GxP, legali e normativi, nonché attraverso audit interni, KPI (Key Performance Indicators) e KQI (Key Quality Indicators).
~Supporta la preparazione e la gestione di audit esterni e aziendali e ispezioni delle Autorità Sanitarie.

**About the Role**:
Major Accountabilities

~ Pianificazione e supporto attivita' PQR/APQR
~ Sito di qualifica supporto e attivita' di validita' (Pianificazione, suggerimento, revisione)
~ Impremento del Sistema di Qualità (incl. gestione documenti)
~ Attività di gestione dei fornitori (accordi, supervisione, audit)
~ Preparazione/sostegno e coordinamento del CAPA/follow-up
~ Accordo e preparazione ispezione e supporto
~ Cambio controllo approvo
~ Garantire la supervisione locale di DI ed eCompliance (formazione, ispezioni, piano, ID rischio, ecc.)
~ Assicurare controllo di processi di qualita' con I regolamenti
~ Revisione e approvazione della dichiarazione QP
~ Trend KPI
~ Assicurare applicazioni, certificati di manutenzione ecc ai HA locali
~ SPOC per la comunicazione con HA, GCA / One voice / approccio consolidato / sinergie per tutti i siti all'interno della stessa giurisdizione / paese HA
~ Segnalazione di reclami tecnici / eventi avversi / scenari di casi speciali relativi ai prodotti Novartis entro 24 ore dal ricevimento
~ Distribuzione di campioni di marketing (se del caso)

Key Performance Indicators

~Supporta attività, operazioni e sistemi efficaci di conformità GxP e/o audit per garantire la conformità delle aree aziendali al Manuale e alle politiche di qualità di Novartis e a tutti i pertinenti requisiti GxP, legali e normativi, nonché attraverso audit interni, KPI (Key Performance Indicators) e KQI (Key Quality Indicators).
~Supporta la preparazione e la gestione di audit esterni e aziendali e ispezioni delle Autorità Sanitarie.

Work Experience

~QC/QA nel settore farmaceutico/biotecnologico con monitoraggio ambientale e zone di pulizia

**Skills**:
~Qa (Garanzia di qualità)
~Procedure Gmp
~Standard di qualità
~Intelligenza Tecnologica
~Orientato all'azione
~Abilità funzionali
~Ottimizzazione dei processi
~Gestire l'ambiguità
~Consapevolezza di sé
~Apprendimento continuo
~Competenza tecnologica

Language

Inglese

Division

Operations

Business Unit

Innovative Medicines

Location

Mexico

Site

INSURGENTES

Company / Legal Entity

BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A

Functional Area

Quality

Job Type

Full time

Employment Type

Regolare

Shift Work

No

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