APR & CPV Specialist - Pharmaceutical Industry

2 mesi fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Job Summary

We are seeking a highly skilled APR & CPV Specialist to join our team at Thermo Fisher Scientific Inc. The successful candidate will be responsible for collecting and analyzing data, drafting reports, and ensuring compliance with regulatory guidelines.

Key Responsibilities
  • Collect and analyze production data, analytical results, and other relevant information to draft Annual Product Review Reports.
  • Implement the Annual Product Review Report for commercial products, ensuring accuracy and compliance with regulatory guidelines.
  • Gather information and draft Periodic Review Reports for Utilities, including validations, change control, specifications, and analytical results.
  • Conduct trend analysis and ensure the completion and accuracy of Periodic Review Reports.
  • Evaluate technical documentation and acquire information necessary for writing Risk Assessments for Continued Process Verification.
  • Draft monitoring protocols for CPV by researching and acquiring data and information from various company functions.
  • Analyze data and report results through accurate drafting of CPV reports.
Requirements
  • A consistent record in data analysis and report writing within the pharmaceutical industry.
  • Exceptional attention to detail and ability to identify trends and patterns in complex data sets.
  • Strong knowledge of regulatory guidelines and standards (GMP, FDA, EMA, etc.).
  • Proficiency in statistical tools and software.
  • Excellent communication skills and ability to collaborate effectively with cross-functional teams.
About Thermo Fisher Scientific Inc.

We are a world-class organization committed to empowering our customers to improve global health, environmental cleanliness, and safety. Through our inventive solutions and advanced technologies, we aim to provide impeccable products that meet the most stringent quality requirements.



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