GCP Specialist R&D Auditing Department

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fxg48

Chiesi Research & Development

Our R&D; team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D; project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for

This is what you will do

To verify and ensure the compliance and the correct application of Good Clinical Practices (GCP) being primarily responsible for the management of all the GCP CAPAs, preparation of the quality metrics, KPIs supporting the compliance inside Global R&D; Departments, management of Quality Documents and by execution of first and second party audits.

You will be responsible for




- Management of CAPA Plans from GCP audits
- Management of the requests for the collection of quality metrics, KPIs supporting Global R&D; Departments
- Management of Trackwise, Suppliers and Audit workflows
- Support the management of external consultants supporting the Auditing & Supplier Qualification Unit.
- Finalization of Quality Documents supporting the Auditing & Supplier Qualification Unit.
- Write/Review SOPs relating to audit and qualification of clinical service providers
- Ensure training on relevant activities and procedures
- Ensure good documentation and traceability
- Execution of GCP first and second party audits
- Finalization and management of the GCP audit reports

You will need to have
- At least 1 year of experience in Pharmaceutical, Consultancy Companies or Contract Research Organization in the Research & Development environment Quality Assurance with knowledge of GCP

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fxg48