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Global Process Validation Expert

1 mese fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
Main Responsibilities

The ideal candidate will act as a point of contact for Global Manufacturing functions 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.

Additionally, the candidate will be responsible for root cause analysis of material/product/production process deviation and OOS, using multiple data sources and data interpretation methods.

The candidate will also align and collaborate with GMD PM to define Lifecycle Management action plan, accountabilities and ensure LCM initiatives monitoring.

Furthermore, the candidate will support Global Manufacturing PMs with the preparation of key deliverables for governing bodies updates on Lifecycle Management activities.

The candidate will participate constructively or coordinate Extended Teams and work packages development meetings when required.

The candidate will also collaborate with Virtual Plant Managers and Procurement in defining commercial agreements technical contents.

Finally, the candidate will 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 making
  • Negotiation skills
  • Goal orientation
  • Leadership and social influence
  • Planning and organizational skills

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.

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.