QA Officer Operations

For our pharmaceutical client, based in Amsterdam region, we are looking for a QA Officer Operations.

The role:

• Review batch documents and all other relevant documents from the production departments. You ensure in collaboration with the responsible employees that errors in the documentation are corrected;
• Ensure strict compliance with GMP procedures within Production. Check compliance with GMP procedures (for example logbooks, order and tidiness, documentation, etc.).
• Ensure operational compliance and progress by frequent presence on the shop floor and by means of (random) checks. You identify and initiate corrective measures where necessary and provide immediate feedback on this;
• Participate in investigations and corrective actions related to quality issues;
• Participate in internal GMP inspections and customer inspections;
• Perform spot audits and formulate the CAPA in collaboration with the QA department;
• You participate in special interdisciplinary task groups where Production input is desired;
• Ensure correct administration (Trackwise) with regards to production-related Changes/Deviations, training courses and CAPAs;
• Support Production management with regards to all developments in the field of quality, GMP and legal guidelines and you play an important role in further and broader integration of quality in the company.