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Pharmaceutical Development Specialist

2 mesi fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
About the Role

We are seeking a highly skilled Pharmaceutical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our PDS Analytical Development GMP Department, you will be responsible for ensuring the successful continuation of projects within the Pharmaceutical Department.

Key Responsibilities
  • Responsible for the analytical documentation of APIs, Excipients, and DP (release and stability tests).
  • Collaborate with Clients, QC PDS, Regulatory Department, QC Compliance, QA, and QO to issue correct documents for PDS projects, respecting ICH and Pharmacopoeia.
  • Provide compliance consulting and strategic advice to internal and external clients to determine the most appropriate approach for compliant documentation.
  • Develop project-specific strategies, provide technical expertise in QC documentation matters, and coordinate oversight for key client projects.
  • Serve as the executive contact for key clients, ensuring quality performance for managed projects.
  • Evaluate OOS, OOT, and laboratory investigations, defining CAPAs and performing laboratory investigations, OOS, and OOT, and deviations related to them.
Requirements
  • Bachelor's degree in chemical engineering, chemistry, or equivalent work experience with pharmaceutical companies.
  • GMP standards applied to Quality Control laboratories, with particular reference to stability studies, laboratory data management, and SOP writing.
  • English and Italian proficiency.
  • Flexibility and adaptability.
  • Good organization and planning skills.
  • Excellent listening, oral, and written communication skills.
  • Ability to work in a team.
About Thermo Fisher Scientific

At Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer. With revenues of over $40 billion and the largest investment in R&D in the industry, we provide our people with the resources and opportunities to create significant contributions to the world.