GCP specialist R&D Auditing Department

Questa posizione è in Chiesi Group

Riassunto dell'opportunità da parte della Joinrs AI : Chiesi Group ricerca un GCP Specialist con laurea scientifica e almeno 3 anni di esperienza in Quality Assurance in ambito farmaceutico o di Ricerca e Sviluppo. Il ruolo prevede la gestione di audit GCP, CAPA, e documentazione qualità per assicurare la conformità. Offre contratto a tempo indeterminato , lavoro ibrido da Parma , RAL a partire da €46.000 con bonus annuale e pacchetto benefit completo, inclusi assistenza sanitaria e programmi di benessere.

Il processo di selezione sarà interamente gestito da Chiesi Group.

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# GCP specialist R&D Auditing Department

Date: 2 Jul 2026

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.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

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

Who we are looking for

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 3 years’ experience in Pharmaceutical, Consultancy Companies or Contract Research Organization in the Research & Development environment Quality Assurance with robust knowledge of GCP supporting clinical trials and knowledge of compliance
• Knowledge of GCP requirements and quality system
• Knowledge of the pharmaceutical development process supporting clinical trials
• Knowledge of training technique
• Scientific degree
• Good knowledge of English

We would prefer for you to have

• Knowledge of