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Compliance Specialist

Compliance Specialist

Amaris ConsultingSingapore
23 days ago
Job description

Job description

ABOUT THE JOB

  • Conduct internal audits and follow up on CAPAs (discussions, responses, and management of open CAPAs)
  • Lead projects related to Data Integrity (audit trail review, data mapping of critical processes)
  • Support external inspections through coordination, logistics, and backroom activities
  • Act as Compliance Partner in inspection readiness initiatives
  • Contribute to Quality Risk Management activities (task monitoring, document review and routing)
  • Assist in the preparation of regulatory submissions (document management and follow-up)
  • Participate in the definition and follow-up of site Quality Metrics and Management Review
  • Collaborate in the execution of the site Quality Plan and continuous improvement projects

ABOUT YOU

  • Academic background : engineering school or equivalent in Life Sciences or Quality
  • Experience in internal audits and support of external inspections
  • Experience in GMP manufacturing environments (API or Biologics production)
  • Knowledge in operational technology (OT) and IT systems (DeltaV, MES, SAP, LIMS...)
  • Strong understanding of Data Integrity and Data Governance principles
  • You have a quality and compliance mindset, and can work in cross-functional environments
  • You have an ability to work autonomously and synthesize complex topics

    • WHY AMARIS?

    At Amaris Consulting, we believe in creating a thriving, positive workplace where every team member can grow, connect, and make a real impact. Here’s what you can expect when you join our dynamic community :

  • Global Diversity : Be part of an international team of 110+ nationalities, celebrating diverse perspectives and collaboration.
  • T rust and Growth : With 70% of our leaders starting at entry-level, we’re committed to nurturing talent and empowering you to reach new heights.
  • Continuous Learning : Unlock your full potential with our internal Academy and over 250 training modules designed for your professional growth.
  • Vibrant Culture : Enjoy a workplace where energy, fun, and camaraderie come together through regular afterworks, team-building events, and more.
  • Meaningful Impact : Join us in making a difference through our CSR initiatives, including the WeCare Together program, and be part of something bigger.
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    Compliance Specialist • Singapore