Qa Systems Specialist

16 ott - Bardi
Grünenthal

OverviewIn Grünenthal's Manufacturing & Global Operations, you help safeguard product quality across the value chain by leading change controls, PQR issuance, CAPA-driven improvements, and master data validation.
You collaborate with cross-functional teams to ensure regulatory compliance and licensing obligations are met while driving continuous quality improvements.
This role offers hands-on QA responsibilities with meaningful impact on patient safety and product excellence.
Retribuzione / Benefitsperformance-based annual premio
equal employment opportunities
ResponsabilitàManage change controls across sites
Plan and execute site trainings
Issue and revise Product Quality Reviews (PQR)
Participate in self-inspections and CAPA management
Revise Master Batch Records
Issue validation protocols and reports




Participate in risk assessment management
Cooperate in revising qualification and validation documentation
Oversee Quality Agreement with customers
Support regulatory activities to maintain manufacturing licenses
Collect and monitor site KPIs
Requisiti fondamentaliDegree in Scientific disciplines
3–5 years of experience in Quality Assurance within pharmaceutical sector
Knowledge of local and international regulatory requirements and GMP standards
Competency in communication and interfaces management
Fluent English
communication
stakeholder management
team collaboration
GMP knowledge
regulatory compliance
CAPA

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