QA Systems Specialist

13 ago - Origgio
Altro

Responsibilities
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
Degree in Scientific disciplines
3–5 years of experience 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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