Quality Assurance Specialist
4 weeks ago
AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that solve serious health issues. We are seeking a highly skilled Quality Assurance Associate to join our team in Maidenhead.
Job Summary:
The Quality Assurance Associate will be responsible for providing commercial quality support in the affiliate, ensuring compliance with corporate, governmental, and local regulations. This role will involve designing effective quality systems, procedures, and processes to ensure efficiency and compliance throughout our quality systems.
Key Responsibilities:
- Integration of local quality regulations for drugs, biologics, devices, and cosmetics
- Design and implementation of quality systems, procedures, and processes
- Planning, preparation, review, and approval of quality documentation
- Support for self-inspections, internal, external, and MoH audits
- 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
- Support for all activities governed by Good Storage and Distribution Practices
Requirements:
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or equivalent professional experience
- Experience in quality assurance, GMP, or GDP environment
- Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault
- Full understanding of local GxP requirements, including regulations and standards affecting devices, biologics, pharmaceutical products, and cosmetics
- General knowledge and understanding of AbbVie's products and regulations
What We Offer:
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. We offer a highly competitive salary, bonus, and comprehensive benefits package.
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