Quality Control Specialist

hace 1 semana


Madrid, Madrid, España Moderna A tiempo completo
About the Role

We are seeking a highly skilled Quality Control Chemistry & Stability Associate II to join our team in Madrid, Spain. As a key member of our quality control laboratory, you will play a crucial role in cGMP QC testing, focusing on QC Chemistry, release, and stability activities.

Responsibilities
  1. Conduct trending and statistical analyses per ICH guidelines.
  2. Create and manage stability protocols, reports, and GMP stability study documents.
  3. Support stability chamber maintenance, troubleshooting, and data interpretation.
  4. Assist with regulatory submissions by providing stability data and reports.
  5. Manage inventories for GMP stability drug substance and products.
Requirements
  • BA/BSc in Chemistry (preferred) or other relevant scientific discipline.
  • At least 5-7 years of experience in quality control laboratory of a pharmaceutical company.
  • Hands-on experience with analytical chemistry testing, including chromatographic techniques, spectroscopic and spectrometric techniques, physical properties techniques, and others.
  • Hands-on experience with stability testing and related activities, including database management, trend analysis, SOP development, and regulatory compliance.


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