Senior Quality Assurance Specialist
4 weeks ago
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 effectively in a team setting and independently.
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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