QA Systems Specialist

09 ago - Origgio
Jobtailor

Responsibilities

L'esperienza richiesta ai candidati, così come le competenze e le qualifiche aggiuntive necessarie per questo lavoro, sono elencate di seguito.

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- Management of change controls

- Participation in planning and execution of site trainings

- Issuance and revision of Product Quality Review (PQR)

- Participation in planning and execution of self‑inspections together with CAPA management

- Revision of Master Batch Records

- Issuance of process validation protocols and reports

- Participation in risk assessment management

- Cooperation in the revision of qualification and validation documentation

- Overview on Quality Agreement with customers

- Participation in management of regulatory aspects to maintain required manufacturing licenses

- Collection of site KPIs

Requirements

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- Degree in Scientific disciplines

- 3–5 years of experience xysqume in Quality Assurance positions within the pharmaceutical sector

- Knowledge of the local and international legal/regulatory requirements and GMP standards

- Competency in communication and interfaces management

- Fluent English

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