APR Specialist

Thermo Fisher Scientific

  • Ferentino, Frosinone
  • Tempo indeterminato
  • Full time
  • 2 giorni fa
Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionWe are seeking a highly skilled and motivated APR specialist to join our team. The successful candidate will work directly within the operational contexts listed below, following the mentorship of the department head.Key Responsibilities:
  • Annual Product Review (APR): Draft and compile comprehensive Annual Product Reviews
  • Risk Evaluation for APR Management: Focus on risk evaluations for the management of APR, including management of findings (ie.Out of Trend (OOT)) identified during the APR drafting.
  • Interdepartmental and Client Interface: Act as a liaison with other internal and external departments, as well as clients, to address critical issues.
  • Audit Participation: Participate in regulatory and client audits.
Qualifications:
  • Master degree in a relevant field (e.g., Chemistry, Pharmacy, Engineering).
  • 1-2 year experience in APR management and working in Pharma Quality Dept.
  • Strong understanding of regulatory requirements and quality management systems.
  • Excellent analytical and problem-solving skills.
  • Statistical knowledge for data evaluation.
  • Effective interpersonal skills.
  • Ability to work with cross-functional teams.
  • Thorough with strong organizational skills.

Thermo Fisher Scientific