15 set - Parma
Chiesi Farmaceutici
Department: Global R&D; Quality Assurance
Business Area: Quality
Job Type: Direct Employee
Contract Type: Permanent
Location: Parma, IT
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
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).
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 Docu
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