Quality Compliance Specialist II

📋 Description

• Support the execution of site quality compliance programs to ensure site adherence to AbbVie
• Support site quality compliance programs for Internal Audit and External Inspection Management
• Support in inspection management activities to ensure site inspection readiness for regulatory
• Support internal lead auditor to perform self-inspection as co-auditor.
• Support Compliance Partner Program, in assigned site departments, to ensure compliance to the
• Support in activities for Product Complaints, Recall Management, Quality Manual/ Site Master File

🎯 Requirements

• Bachelors / Masters in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences
• A minimum of 2-5 years in a cGMP regulated environment is required.
• A minimum of 2 years of relevant experience in compliance and audit is preferred.
• Specialization in quality / compliance areas such as audit management, product review, customer
• Good knowledge of regulatory standards and guidelines (such as ICH, CFR, Eudralex, PIC/S) is
• Proven problem-solving skills and the ability to adapt to changes is preferred.