Commercial Compliance Expert

4 days ago


Hong Kong, Central and Western District, Hong Kong SAR China Allergan Full time
Quality Assurance Role:
We are seeking a talented Commercial Quality Specialist to join our team at Allergan. As a quality assurance professional, you will play a critical role in ensuring the quality of our commercial products and services. Your expertise will help us maintain compliance with corporate, governmental, and local regulations, while also driving continuous improvement and excellence in our quality systems and processes. 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.

Requirements:
  • 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.

About Our Company:

Allergan is an innovative, patient-focused pharmaceutical company dedicated to delivering life-changing treatments that improve people's lives. We're proud of our heritage and our legacy of making a meaningful difference in the world. If you share our passion for making a difference, we invite you to explore our job opportunities and consider joining our team.



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