Corporate Quality Auditing Specialist

**Date**:Apr 7, 2025

**Department**:Corporate Quality Operations

**Job Type**:Direct Employee

**Business Area**:Quality

**Contract Type**:Permanent

**Location**:Parma, IT

**_About us_**
- Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 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 have been awarded with **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); Blois-La Chaussée-Saint-Victor (France); Santana de Parnaíba (Brazil). The plants produce a total of over 110 million units per year.
- The production plant in Parma covers a total area of more than fifteen thousand square meters and it is the strategic hub for the production and distribution of our products, being an international supply center that exports to more than 80 countries. The Parma plant produces solid medicinal products, such as tablets and inhaled dry powders; inhalation solutions and suspensions, either pressurized or sterile single-dose vials; vials of sterile suspension for endotracheal administration; liquid forms such as drops, syrups and nasal sprays.
- Santana produces pressurized solutions and suspensions for inhalant therapy (MDIs) and supplies both domestic market and Group’s Affiliates and exports to licensees and distributors. Blois specializes in Dry Powder Inhalers and final assembly stages of the Metered-Dose Inhalers (MDIs), supplies Group’s Affiliates and distributes directly to clients at a local level and in export markets.

**_Who we are looking for_**

**Purpose**
- 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
- Participes to the review of procedure and documentation related to the supply chain map, quality agreement
- Participates in investigations into non-conformities of materials in acceptance
- Maintains contact with the internal representative and the global supplier in order to promote the removal of non-conformities, which caused the problems with the material supplied, and the implementation of the necessary corrective actions
- Participates in evaluations of change control in relation with suppliers, CMO, and GxP service providers
- Evaluates the impacts on the qualification of GxP suppliers, CMO, services providers, and related GxP audits, quality agreement, validation report, and suppor