Job Summary

You will join the Quality Assurance department and you will be involved in ensuring both document and operational compliance related to plasma and plasma intermediates. You will collaborate with production, regulatory, and auditing functions, handling control activities, operational support, and continuous improvement initiatives, all in accordance with current regulations and the company’s quality standards.

What you'll do

• Verify the accompanying documentation for plasma and plasma intermediates during both pre-import and pre-release phases for production, ensuring regulatory compliance and proper archiving.
• Collaborate with the production team to ensure accurate and compliant documentation in accordance with GMP and company quality standards.
• Interface with suppliers to manage documentation anomalies, investigate root causes, and verify the implementation of corrective actions.
• Participate in drafting Quality Agreements with plasma and plasma intermediate suppliers.
• Support the execution of self-audits and supplier audits, following up on the implementation of corrective actions.
• Gather regulatory information from plasma suppliers required for the preparation of necessary documentation.
• Contribute to the drafting and updating of operational procedures within the organizational unit and support staff training activities.
• Manage deviations related to the supply of plasma and plasma-derived raw materials, ensuring proper documentation and assisting in investigations.
• Supervise activities related to verifying the compliance of production environments with GMP (housekeeping) and perform Quality on the Floor activities.
• Review production Batch Records and manage the opening and closing of production Logbooks in accordance with GMP.
• Propose improvements and participate in projects aimed at optimizing processes and ensuring regulatory compliance.
• Analyze updates to relevant regulations and guidelines.
• Track donations involved in non-compliance reports, trace the processing pool, and share information with other Quality Assurance departments to support necessary actions.
• Participate in risk analysis activities and review related documentation.

Qualifications and need-to-know

• High school diploma or university degree in a technical or scientific field.
• Previous experience in the pharmaceutical sector, particularly in Quality or Quality Assurance, is preferred.
• Good knowledge of the English language.
• Proficiency in using IT systems.
• Excellent communication skills.
• Strong team-working attitude.