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Global Process Validation Expert

2 mesi fa


Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
About the Role

We are seeking a highly skilled Global Process Validation SME to join our Corporate Products Industrialization department. As a key member of our team, you will be responsible for coordinating maintenance activities on in-market products, ensuring compliance with regulatory frameworks, and collaborating with internal and external stakeholders.

Main Responsibilities
  • Act as a point of contact for Global Manufacturing functions on technical expertise for maintenance activities, including maintenance needs collection, planning, and execution.
  • Conduct root cause analysis of material/product/production process deviations and OOS, using multiple data sources and data interpretation methods.
  • Align and collaborate with GMD PM to define Lifecycle Management action plans, accountabilities, and ensure LCM initiatives monitoring.
  • Support Global Manufacturing PMs with the preparation of key deliverables for governing bodies updates on Lifecycle Management activities.
  • Participate in Extended Teams and work packages development meetings, and collaborate with Virtual Plant Managers and Procurement in defining commercial agreements technical contents.
Requirements
  • At least 5 years' experience in development/scale-up or technology transfer in international pharmaceutical environments.
  • Bachelor's or Master's Degree in scientific disciplines (CTF, Pharmacy, Biotechnology, etc.).
  • Fluent English (both written and spoken).
  • Sound competences in pharmaceutical technologies, Lean Six Sigma, and Six Sigma methods.
  • Good knowledge of pharmaceutical legislation and main international regulatory frameworks (cGMP, EMA guidelines, FDA, and ICH).
What We Offer

You will join a dynamic, fast-growing, and friendly environment where we invest in continuous training, learning, and development. We strive to promote and satisfy development needs, paying attention to the quality of our working environment and collective well-being. We offer flexible working approaches, remote working, support in relocation processes, tax assistance services, and many other people-care services.