Sr Quality Assurance Specialist
Updated: March 08, 2024 09:31 AM GMT
Full-time Job in Solna, Stockholm County
ABBVIE
Solna, SwedenThe Commercial Quality Assurance (QA) Specialist is responsible for ensuring quality support for pharmaceutical products, medical devices, biologics, and cosmetics in Sweden. Key responsibilities include managing Quality Manual requirements, Supplier Controls, Risk Management, CAPA, and Agency inspections/internal audits. The Specialist ensures that all quality activities from product receipt to distribution comply with corporate, governmental, and local regulations. The Commercial Quality Specialist will also support the Scandinavian Commercial Quality team.
Key Responsibilities include:
• Integrate local quality regulations for drugs, biologics, device/combination products, and cosmetics.
• Design quality systems, procedures, and processes to ensure compliance and efficiency.
• Assess compliance to processes, procedures, and regulations to identify potential gaps and implement improvements.
• Support internal, external, and MoH audits.
• Coordinate and investigate quality events... More Detail
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