Senior QA Systems Specialist

14 set - Origgio
Grünenthal

Overview

In 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 / Benefits

- performance-based annual premio
- equal employment opportunities

Responsabilità

- Manage 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 fondamentali

- Degree 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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