Quality Assurance Specialist

3 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time
Job Description

AbbVie is seeking a highly skilled Quality Assurance Specialist to join our team in Maidenhead. As a key member of our quality team, you will be responsible for ensuring the quality of our pharmaceutical products, medical devices, and combination products.

Key Responsibilities:

  • Provide quality support in the affiliate, ensuring compliance with corporate, governmental, and local regulations.
  • Design and implement effective quality systems, procedures, and processes to ensure efficiency and compliance.
  • Plan, prepare, review, and approve quality documentation, including change controls and product reviews.
  • Support self-inspections, internal, external, and MoH audits as directed by the manager.
  • Coordinate and investigate quality events, including deviations, non-conformances, and corresponding action plans.
  • Execute supplier qualification programs, including performance monitoring for key suppliers.
  • Support activities governed by Good Storage and Distribution Practices, including monitoring of controlled temperature and cold chain shipments.

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 device, biologics, pharmaceutical products, and cosmetics.
  • General knowledge and understanding of AbbVie's products and regulations.
  • Ability to support projects as a team member as assigned by manager.

About AbbVie:

AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.



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