QA Operation Expert

Switzerland, Project Duration: 18 Months
Location:
City: Stein
Country: Switzerland
  • Ensure compliance according to the Novartis internal quality standards, relevant regulatory requirements and the filed product quality standards.
  • Ensure QA monitoring of the allocated products in the QC organization. Manage all quality aspects of a portfolio of products in terms of re-lease, validation, qualification, deviations, change and transfer work, in the QC and AST laboratories.
  • Perform the technical batch release decision in SAP. This role requires adherence to specific cGMP requirements and execution according to the valid SOP's.
  • The person does support the QA/QC oversight and is doing QA driven projects on requests.

Requirements:

Language:
  • German fluent verbal and written
  • English good verbal understanding, technical understanding

Education (minimum/desirable):
(Technical) University/academy degree in chemistry, pharmacy or equivalent

Experience:
  • Professional experience in quality control/quality assurance or in the manufacturing of pharmaceutical drug products.
  • Laboratory Equipment qualification and calibration