Global Process Validation Sme

4 settimane fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

**Date**:Aug 29, 2024**Department**:Corporate Products Industrialisation**Job Type**:Direct Employee**Team**:Industrial Operations & HSE**Contract Type**:Permanent**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 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 figure will act as a Subject Matter Expert of Process Validation and technical maintenance activities within the Corporate Products Industrialization department and will interface with internal and external stakeholders as R&D, Operations and contract manufacturers/subcontractors. He/She will be responsible for coordinating of maintenance activities on in-market products (pMDI).

**Main Responsibilities**
- Act as point of contact for Global Manufacturing functions (incl. plant Site Process SME) on technical expertise for maintenance activities for in-market products, regarding maintenance needs collection, planning and execution, challenges identification and reporting to dedicated governance bodies, including plant Site Process SME (Chiesi sites & CMO);
- Act as point of contact for root cause analysis of material/product/production process deviation and OOS, using when required multiple data sources and data interpretation methods;
- Align and collaborate with GMD PM to define Lifecycle Management action plan, accountabilities and ensure LCM initiatives monitoring;
- Support Global Manufacturing PMs with the preparation of key deliverables for governing bodies updates on Lifecycle Management activities (e.g., business cases);
- Participate constructively or Coordinate Extended Teams and work packages development meetings when required (e.g., ETTs, Technical Maintenance, Operative Teams);
- Collaborate with Virtual Plant Managers and Procurement in defining commercial agreements technical contents;
- Participate to diligence activities in projects involving more disciplines, as needed.

**Experience Required**
- At least 5 years’ experience in development / scale-up or technology transfer in international pharmaceutical environment.

**Education**
- Bachelor's or Master's Degree in scientific disciplines (CTF, Pharmacy, Biotechnology, etc.)

**Languages**
- Fluent English (both written and spoken)

**Technical Skills**
- Sound competences in pharmaceutical technologies as pMDI (preferred) / Sterile products/ DPI;
- Good Knowledge on Lean Six Sigma and Six Sigma methods;
- Good knowledge of pharmaceutical legislation and main international regulatory frameworks (cGMP, EMA guidelines, FDA and ICH).

**Soft Skills**
- Communication skills
- Decision mak

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