Quality Systems Specialist

4 days ago


Hong Kong, Central and Western District, Hong Kong SAR China Allergan Full time
Job Description:
The Commercial Quality Specialist plays a crucial role in ensuring the quality of commercial products and services at Allergan. This position requires strong analytical and problem-solving skills, as well as excellent communication and collaboration abilities. The ideal candidate will have a deep understanding of quality systems, procedures, and processes, as well as experience working in a GMP or GDP environment. Key responsibilities include:
  • Providing commercial quality support to ensure compliance with corporate, governmental, and local regulations.
  • Designing and implementing effective quality systems, procedures, and processes within cross-functional teams.
  • Conducting assessments to determine compliance with processes, procedures, and regulations, identifying potential gaps and implementing improvements.
  • Planning, preparing, reviewing, and approving quality documentation such as change controls and product reviews.
  • Supporting internal, external, and MoH audits, leading self-inspections as necessary.
  • Coordinating and investigating quality events, including deviations, non-conformances, and corresponding action plans.
  • Executing supplier qualification programs, including performance monitoring for key suppliers.
  • Monitoring metrics and KPIs to ensure compliance.
  • Supporting activities governed by Good Storage and Distribution Practices, including monitoring of controlled temperature and cold chain shipments.
  • Supporting the Management Review process for the affiliate.

Key Qualifications:
  • Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred.
  • 3+ years experience in quality assurance, GMP, or GDP environment preferred.
  • Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault required.
  • Full understanding of local GxP requirements, including regulations and standards affecting device, biologics, pharmaceutical products, and cosmetics.
  • General knowledge and understanding of AbbVie MD, pharmaceutical, biologic, and cosmetic products and regulations.

Additional Information:

Allergan is committed to creating an inclusive work environment where all employees feel valued and respected. We believe that a diverse and inclusive workplace drives innovation and fosters growth, ultimately benefiting our customers and communities. If you share our commitment to diversity and inclusion, we encourage you to apply.



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