Commercial Quality Expert
1 week ago
The Senior QA Specialist is responsible for providing commercial quality support in the affiliate. The scope of activities includes quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics, and cosmetics. 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. The Sr. Specialist has an in-depth knowledge of one or more elements and is considered a subject matter expert in these areas. 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.
Main Responsibilities:
* Integration of local quality regulations for drugs, biologics, devices, and cosmetics
* Design of effective quality systems, procedures, and processes within cross-functional teams
* Assessment of compliance to processes, procedures, and regulations
* Planning, preparation, review, and approval of quality documentation
* Support for internal, external, and MoH audits as directed by the manager
* Coordination and investigation of quality events, including deviations, non-conformances, and corresponding action plans
* Execution of supplier qualification program, including performance monitoring for key suppliers
* Monitoring of metrics and KPIs to ensure compliance
* Support for all activities governed by Good Storage and Distribution Practices, including monitoring controlled temperature and cold chain shipments
* Representation of Commercial Quality in cross-functional teams, projects, and programs as assigned by management
Requirements:
* Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred
* 3+ years experience in quality assurance, GMP, or GDP environment preferred
* Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault
* Full understanding of local GxP requirements, including regulations and standards affecting device, biologics, pharmaceutical products, and cosmetics
* General knowledge and understanding of AbbVie MD, pharmaceutical, biologic, and cosmetic products and regulations
* Ability to support projects as a team member or lead as assigned by manager
* Experience working in both a team setting and independently
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