Corporate Quality Auditing Specialist - Temporary

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**Date**:23 Jun 2025 **Department**:Corporate Quality Operations **Business Area**:Industrial Operations & HSE **Job Type**:Direct Employee **Contract Type**:Temporary **Location**:Parma, IT **_About us_**
- Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas**:Discover more here**
- We are proud to be the largest global pharmaceutical group to be awarded **B Corp Certification**, a recognition of **high social and environmental standards**. We are a **reliable** company that adopts and promotes a **transparent and ethical behavior** at all levels.
- We believe that the success of **Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors**. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
- We are committed to **embrace diversity, inclusion and equal opportunities.** In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. **_Chiesi Global Manufacturing Division_**
- Chiesi Group has three production plants:
**Parma** (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers,



solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.
- In 2024, a new **Biotech Centre of Excellence** has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins. **Blois-La Chaussée Saint Victor plant** (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs. **Santana de Parnaiba** (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).
- In 2025, a new investment in **Nerviano** (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon mínimal inhalers (reinforcing the company’s commitment to both patients’ health and sustainable healthcare solutions), dry powder inhalers and sterile biological products. **_Who we are looking for_** **Purpose**




- We are looking for a Corporate Quality Auditing Specialist to join our corporate team on a temporary contract.- The collaborator will be specialized in: - Carrying out GxP/ISO audits of GMD contractors in full authonomy,
- Drafting quality agreements,
- Ensuring supplier qualification and validation according to GxP requirements and Chiesi quality standards,
- Ensuring the quality of global suppliers and monitoring their quality performance. **Main Responsibilities**
- Within the scope of Good Manufacturing Practices (GMP), Good distribution practices (GDP) and ISO 9001:2015 standards:
- Collaborates in internal/external audit activities at every stage: - Planning and updates
- Collaborates in the issuing of annual audit plans (internal/external)
- Preparation (material collection, procedures, other official documentation)
- Drafting of the Audit agenda
- Contacts to be made with the supplier to be inspected
- Conducting the audit in Europe and Worldwide
- Drafting of the report in English
- Check proposed corrective actions
- Keeps the progress of audits updated, monitoring the progress and closure of corrective action
- Verification of the effectiveness of corrective actions
- Draws up synoptic tables on the general situation of the Audits (useful activity also for management review)
- Participates in the drafting of the main sector operating procedures, defining their structure, requirements, etc.
- Keeps up-to-date the procedures related to GxP suppliers and service providers qualification, validation, maintenance, and quality risk management, and related instruction, template, user guide
- Keeps up-to-date the procedure related to GxP audits and related instruction, template, user guide
- Participates to the review of procedure and documentation related to the supply chain map, quality agreement
- Partici

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