Quality Systems Specialist

7 days ago

Hong Kong, Central and Western District, Hong Kong SAR China Allergan Full time

About Us

AbbVie is a leading global biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

Our Mission

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.

Job Summary

The Commercial Quality Specialist will be responsible for independently providing Commercial Quality support in the affiliate. Scope of activities includes quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics, and cosmetics.

Key Responsibilities

  • Responsible for the integration of local quality regulations for drugs, biologics, device and/or combination products, and cosmetics.
  • Design effective quality systems, procedures, and processes within cross-functional teams to ensure compliance as well as efficiency throughout our quality systems.
  • Work on assessments to determine compliance to processes, procedures, and regulations to identify potential gaps and mitigate and implement improvements.
  • Plan, prepare, review, and approve quality documentation such as change controls, product reviews, and other local requirements.
  • Support internal, external, and MoH audits as directed by the manager, lead self-inspections.
  • Coordinate and investigate quality events such as deviations, non-conformances, and corresponding action plans including decisions.
  • Execute supplier qualification programs, 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.

Requirements

  • Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred.
  • 3+ years of experience in quality assurance, GMP, or GDP environment preferred.
  • Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault.
  • Full understanding of local GxP requirements, including regulations and standards affecting device, biologics, pharmaceutical products, and cosmetics, with an in-depth knowledge in one or more areas.
  • General knowledge and understanding of AbbVie MD, pharmaceutical, biologic, and cosmetic products and regulations.
  • Ability to support projects as a team member or lead as assigned by manager.
  • Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Makes decisions in collaboration with management.
  • Acts as an owner - uses available resources to independently complete assigned tasks.
  • Influencing - Understand your stakeholders and shape communication; can negotiate to win.
  • Personal Presence - Demonstrate the confidence that matches their subject matter expertise and intellectual capacity.

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