Process Validation SME - Parma, Italia - Chiesi Group

Descrizione

Who we are looking for

Purpose

The person will be the Subject Matter Expert of Process Validation and technical maintenance activities within industrialization and product technology transfer and will interface with internal and external stakeholders as R&D, Operations and contract manufacturers / subcontractors. The figure will be also responsible for coordinating maintenance activities for in-market products.

Main Responsibilities

• Act as the key reference person for Manufacturing functions (including 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 (Parma, Blois, Santana, Virtual);

• Align and collaborate with Global Manufacturing PM to define LCM activities action plan, accountabilities and ensure LCM initiatives monitoring;

• Support Global Manufacturing PM with the preparation of key deliverables for governing bodies (TMPT / GMD LT) updates on LCM 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;

• Experience with sterile products is considered as an essential requirement.

Education

Scientific Bachelor's or Master's Degree

Languages

Fluent English (both written and spoken)

Technical Skills

• Sound competences in pharmaceutical technologies as sterile DP (Sterile liquid and sterile liophilized products);

• Good knowledge of laboratory analytical technologies and their applications in processes (PAT);

• Good knowledge of pharmaceutical legislation and main international regulatory frameworks (cGMP, EMA guidelines, FDA and ICH).

Soft Skills

• Adaptability and flexibility
• Communication skills
• Decision making
• Leadership and social influence
• Problem solving
• Proactiveness

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.