QA Systems Specialist

02 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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