Global Process Validation SME
3 mesi fa
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.
At least 5 years’ experience in development / scale-up or technology transfer in international pharmaceutical environment.
EducationBachelor's or Master's Degree in scientific disciplines (CTF, Pharmacy, Biotechnology, etc.)
LanguagesFluent 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).
- Communication skills
- Decision making
- Negotiation skills
- Goal orientation
- Leadership and social influence
- Planning and organizational skills
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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