Purpose:

The Quality Assurance Specialist is responsible for independently providing Commercial Quality support in the affiliate including full management of third-party laboratories conducting post importation testing.  Scope of activities includes quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics. Specific areas of support may include Storage and Distribution, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements.   This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements.    

Responsibilities:

• Responsible for the integration of local quality regulations for drugs, biologics, device and/or combination products and cosmetics.
• Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. 
• Work on assessments to determine compliance with processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. 
• Plan, prepare, review and approve quality documentation such as change controls, product reviews and other local requirements. 
• Support self-inspections, internal, external and MoH audits as directed by the manager.
• Coordinate and investigate quality events such as deviations, non-conformances and corresponding action plans including decisions.  
• Execute supplier qualification and performance monitoring for key suppliers, including third party laboratories. Managing contract/SOW/QTA with the lab.
• Monitor metrics and KPIs to ensure compliance.
• Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
• Support the Management Review process for the affiliate. 
• Represent Commercial Quality in cross functional teams, projects and programs, as assigned by management. 
• Managing timeline for post importation testing at the lab.
• Ensure proper maintenance, calibration, and qualification of AbbVie-owned equipment at the laboratory.
• Managing supplier/audit records in One Track system and supplier qualifications.
• Handle and communicate all change notifications from the laboratory (including SCN process).
• Ensure timely provision of reference standards and critical reagents to the laboratory.
• Ensuring supply of reference standards and critical reagents to the lab.
• Handle and troubleshoot any un-expected results (LIR, OOS) from lab testing. – including ER reporting.
• Communicate testing method changes (STM or locally registered methods) to the lab.
• Ensure ongoing training and compliance with GxP standards for lab personnel as relevant.
• Manage risk assessments and implement improvement actions for lab-related processes.