Questa posizione è in Chiesi Group Il processo di selezione sarà interamente gestito Chiesi Group.
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QA GMP Senior Auditor
Department: Global R&D; Quality Assurance
Contract Type: Permanent
Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. As a Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
We believe our differences make us stronger. 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).
*The role supports the execution of first and second party audits, the qualification and maintenance of R&D; suppliers and service providers, and the definition and management of Quality Agreements.
The position includes a dedicated focus on sterile, biological and biotech products.
Experience in gene therapies or related advanced platforms is considered a plus.
Plan and execute second party audits of GMP suppliers and GMP service providers (CMOs , contract laboratories).
Execute first party audits.
Monitor the follow-up of audit non-conformities and verify the adequacy and timely closure of corrective and preventive actions.
Manage and coordinate external consultants supporti
📌 QA GMP Senior Auditor (Italia)
🏢 Chiesi Group
📍 Italia
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