• Strong CDMO in San Sebastian surroundings
• QA Operations

Strong CDMO company with high-performance project and facilities near San Sebastian.

The holder of this position, reporting to Quality Assurance Director, is a key member of the local management team and plays a major role in the overall management of the site and will lead the Quality Assurance Operations department. In this context he/she is mainly responsible for:

• Continuous improvement of Key Quality Indicators of company
• Lead inspections from regulatory agencies and customer related audits.
• Contact point for GxP departments for deviations, change control and CAPA management derived from production.
• Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
• Collaborates with management and senior staff across production departments and roles to draft acceptable quality standards.
• Participate actively in the digitalization roadmap of company
• Develops and implements quality standard operating procedures.
• Collaborate in daily activities of department such as, deviation and change management.
• Interact with regulatory agencies during inspections.
• Collaborates with customers during product lifecycle.