Quality Assurance

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Fondazione Penta ETS ( penta-id.org ) is looking for a Quality Assurance & Auditing Manager .

Job Responsibilities
The Quality Assurance & Auditing Manager role provides an exciting opportunity for someone with a track record in Quality Assurance and an interest in clinical research. Success in this position involves effectively managing quality standards, developing QA plans, performing audits, and implementing risk management strategies. This role is crucial for ensuring compliance with regulatory requirements and best practices, thereby supporting the company’s overall mission to maintain high-quality standards and continuous improvement.

Reports To
The Quality Assurance & Auditing Manager will report to the Chief of Department.

Job Duties
- Develop QA plans with each team leader, identify critical control points and mitigation strategies
- Perform supplier qualification and monitoring
- Perform audits (internal and external)




- Implement risk management and in-house quality standards at company level to be negotiated with the senior management
- Handle deviations and corrective action / preventive actions (CAPA).
- Manage trainings at company level
- Represent QA in cross-functional project teams that among other things, but not limited to, provide quality guidance and evaluate new processes or quality systems for projects and Phase I/II/III/IV studies
- Manage and approve controlled documents (SOPs, policies and work instructions)
- Provide independent reporting on quality compliance to the Board of Directors.
- Support the operating staff in the implementation of GCP-related quality system SOPs in
- compliance with applicable regulatory requirements and best practice.
- Provide leadership and oversight for continuous process improvement as new issues are detected, new knowledge becomes available, or change in regulation that add greater reliability, compliance, efficiency, and drive change.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77xzi7