Analytical Development Specialist

2 ore fa


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

We are seeking a highly skilled Pharmaceutical Quality Control Expert 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 quality and compliance of our pharmaceutical products.

Key Responsibilities
  • Develop and implement analytical documentation for APIs, excipients, and drug products, including release and stability tests.
  • Collaborate with clients, QC PDS, regulatory department, QC compliance, QA, and QO to ensure accurate and compliant documentation for PDS projects.
  • Provide compliance consulting and strategic advice to internal and external clients to ensure compliant documentation for their products.
  • Develop project-specific strategies and provide technical expertise in QC documentation matters, ensuring quality performance for key/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.
  • Proficiency in GMP standards applied to Quality Control laboratories, with particular reference to stability studies, laboratory data management, and SOP writing.
  • Proficiency in English and Italian.
  • Flexibility and adaptability.
  • Good organization and planning skills.
  • Excellent listening, oral, and written communication skills.
  • Ability to work in a team.
About Us

At Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer. With over 100,000 employees worldwide, we are a global leader in the scientific instrumentation and life science industries. We offer a dynamic and challenging work environment, with opportunities for growth and development.



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