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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📌 QA Systems Specialist (Origgio)
🏢 Jobtailor
📍 Origgio