Supplier Qualification Specialist Full Time NEW

Role Description:

• As a Supplier Qualification Specialist, you will play a key role in ensuring the quality, compliance, and regulatory integrity of external suppliers and contract manufacturing organizations (CMOs). You will support supplier-related quality assurance activities, ensuring alignment with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and applicable regulatory standards.

Key Responsibilities:

• Supplier Quality Support:
  • Execute supplier qualification and performance monitoring activities.
  • Support the implementation of supplier quality strategies in collaboration with procurement and supply chain teams.
  • Ensure documentation and processes meet internal and external compliance standards.
  • Update approved supplier list, handling supplier changes, CAPAs and using Helix (eQMS) for tracking
• Operational Quality Activities:
  • Maintain supplier quality management systems in line with company and regulatory requirements.
  • Monitor supplier KPIs and support continuous improvement initiatives.
  • Participate in investigations related to supplier deviations, complaints, and non-conformities.
• Audits and Qualification:
  • Assist in planning and conducting supplier audits.
  • Follow up on audit findings and ensure timely completion of corrective and preventive actions (CAPAs).
  • Contribute to the assessment and onboarding of new suppliers.
• Compliance and Risk Mitigation:
  • Identify potential risks in supplier quality and escalate issues as needed.
  • Ensure adherence to global regulatory requirements (FDA, EMA, MHRA, WHO, etc.).
• Cross-Functional Collaboration:
  • Act as a quality liaison with suppliers, procurement, and supply chain teams.
  • Provide quality input during supplier selection and due diligence processes.
  • Participate in internal quality forums and working groups as required.