R&D Qms Officer Abano Terme

R&D Qms Officer
Abano Terme
Veneto, Abano Terme

Corporate R&D Quality & Compliance Specialist

With the aim of strengthening the corporate structure We are recruiting for a

** Corporate R&D Quality & Compliance Specialist **who will

** be **supporting the Head of Corporate Clinical Safety, Pharmacovigilance and R&D Compliance in the development and maintenance of the Corporate R&D Quality Management Systems, and its Subsidiaries, with the focus to ensure compliance to all the applicable legal and regulatory requirements, in particular to GCP, GVP.

**Main Responsibilities**:

- Supporting the development and maintenance of the overall Corporate R&D Quality Management System for Pre-Clinical and Clinical research, Pharmacovigilance System, Medical Affairs.

- Supporting the interpretation of GLP/GCP/GVP-related regulations/guidelines (ICH, EU, FDA, etc. )

and translating them into company policies and standard operating procedures.

- Coordinating the preparation of the Quality Management Review and monitoring implementation of any need for improvement.

- Participating in cross-functional teams providing GxP advice and guidance on risk identification and risk-based approach in Quality Management.

- Planning, conduction and reporting of any vendor qualification audit, issuing relevant audit reports and maintaining the Corporate Qualified Vendor Registry.

- Supporting the Head of Corporate Clinical Safety, Pharmacovigilance and R&D Compliance in the coordination of any regulatory inspections and audits.

- Supporting the Head of R&D Quality & Compliance in the development of responses to inspection findings and preparation of the related CAPA plans.

- Management of the Deviation monitoring system to ensure timely remediation of non-compliance, including the performance of any needed Root Cause Analysis, evaluation of suggested CAPAs and assessment of their effectiveness.

- Coordinating the Computerized System Validation activities within the Corporate R&D Compliance Area;

- Coordinating internal GxP training programs and maintaining training documentation.

**Requirements**:

- Minimum 5 years' experience in R&D Quality Management Systems within the Pharma Industry.

- Good knowledge of ISO 9001 standards for Quality Management System in a GxP environment.

- Experience in Vendor Management in GxP (Qualification audit and follow-up) including Audit and Inspection readiness.

- Ideally you will hold experience as GCP & GVP Auditor.

- Good eye for details and comfortable working in a highly regulated environment.

- Fluent in English.