Quality Assurance Specialist - GCP & GVP

The main responsabilities will be:

• Manage Annual Audit Programs, since planning until closure and supervise subcontracted auditors of those fields;
• Manage deviations and change controls in QMS;
• Manage periodic reports, ensuring they are performed timely;
• Host Regulatory Inspections;
• Conduct audits according to the competences defined in the approved Qualification Matrix;
• Monitor Annual Budget;
• Prepare and / or verify SOPs, along with other related documentation;
• Verify the conformity of Quality Management Systems with applicable requirements;
• Comply with the Policies, Standards and Procedures in place;
• Collaborate in all department activities, as needed.