Pharmaceutical Quality Systems Manager

1 week ago

Central And Western District, Hong Kong SAR China Allergan Full time
About the Job

We are seeking a highly skilled Senior Quality Control Professional to join our team. As a member of our affiliate, you will be responsible for providing independent quality support and ensuring compliance with Corporate, governmental, and local regulations.

Key Responsibilities:
  • Quality System Requirements: Ensure that quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics, and cosmetics are met, in line with regulatory standards.
  • Storage and Distribution: Support storage and distribution processes to guarantee product integrity and prevent any deviations from quality expectations, thereby ensuring customer satisfaction.
  • Supplier Controls: Execute supplier qualification programs and performance monitoring for key suppliers, ensuring they meet our quality standards and provide high-quality products.
  • Product Quality Review: Conduct regular product quality reviews to identify potential issues and take corrective actions, minimizing the risk of recalls and reputational damage.
  • Risk Management: Identify and mitigate risks associated with product quality, utilizing your analytical skills to minimize any impact on our business.
  • Audit Preparation: Prepare for internal and external audits, including agency inspections and self-inspections, to ensure that we are always prepared and demonstrate our commitment to quality excellence.
  • CAPA: Investigate and resolve quality events, deviations, and non-conformances in a timely and effective manner, applying your problem-solving skills to find solutions.
  • Quality Manual: Ensure that all quality manual requirements are met and up-to-date, reflecting our commitment to quality excellence and regulatory compliance.
Requirements:
  • Bachelor's Degree: In Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred, with a strong foundation in quality principles.
  • Experience: 3+ years in quality assurance, GMP or GDP environment preferred, with a proven track record of delivering quality results and driving continuous improvement.
  • Computer Skills: Familiarity with SAP, Track Wise, Compliance Wire, and One Vault required, with the ability to quickly learn new systems and technologies.
  • Knowledge: Full understanding of local GxP requirements, including regulations and standards affecting device, biologics, pharmaceutical products, and cosmetics, with the ability to apply this knowledge in a practical setting.

About Us: Allergan, as part of AbbVie, is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.

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