Senior Quality Assurance Specialist

3 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time
Senior QA Specialist Job Description

AbbVie is seeking a highly skilled Senior QA Specialist to join our team in Maidenhead. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our pharmaceutical, biologic, and cosmetic products.

Key Responsibilities:

  • Develop and implement quality systems, procedures, and processes to ensure compliance with regulatory requirements.
  • Conduct assessments to identify potential gaps and implement improvements to our quality systems.
  • Plan, prepare, review, and approve quality documentation, including change controls and product reviews.
  • Support internal and external audits, as well as self-inspections and investigations.
  • Coordinate and investigate quality events, including deviations and non-conformances.
  • Execute supplier qualification programs and monitor key supplier performance.
  • Monitor metrics and KPIs to ensure compliance with regulatory requirements.

Qualifications:

  • Bachelor's degree in a relevant field, such as chemistry, pharmacy, biology, or engineering.
  • Experience in quality assurance, GMP, or GDP environments.
  • Strong computer skills, including 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 work independently and as part of a team, with strong communication and problem-solving skills.

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 are dedicated to creating a workplace where everyone feels valued, respected, and empowered to contribute their best work.



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