Quality Analyst
AbbVie
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. 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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .
Job Description
The Commercial Quality Associate is responsible for providing Commercial Quality support in the affiliate in collaboration with the affiliate QA team and Manager at an operational and regulatory complex commercial entity or multiple commercial entities in support of the quality system requirements associated with pharmaceutical products, medical devices, combination products and biologics.
Responsibilities:
+ Assist with the integration of local quality regulations for drugs, biologics, device and/or combination products and cosmetics.
+ Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
+ Support assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
+ Assist in the planning, preparation, review and approval of quality documentation such as change controls, product reviews and other local requirements.
+ Support self-inspections, internal, external and MoH audits as directed by the manager.
+ Support coordination and investigation of quality events such as deviations, non-conformances and corresponding action plans including decisions.
+ Support management of supplier qualification program including performance monitoring for key suppliers.
+ Monitor metrics and KPIs to ensure compliance.
+ Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
+ Support the Management Review process for the affiliate.
+ Represent Commercial Quality in local cross functional teams, projects and programs, as assigned by management.
Qualifications
+ Bachelor’s degree in chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
+ 0 - 2+ years experience in quality assurance, GMP or GDP environment preferred.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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