Supplier Qualification Specialist
3 days ago
Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets.
With a large footprint reaching patients in over 120 markets, and manufacturing and packaging facilities in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. The companies Acino, Amoun, Birgi Mefar Group, and M8 are all part of Arcera Life Sciences.
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. The job holder will report to Quality Management System Head and will be based in our Egypt site in EL Obour City. The position will be hired on an outsources base for 1 year (could be extended).
Your responsibilities:
- 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
- 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.
- 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.
- Identify potential risks in supplier quality and escalate issues as needed.
- Ensure adherence to global regulatory requirements (FDA, EMA, MHRA, WHO, etc.).
- Act as a quality liaison with suppliers, procurement, and supply chain teams.
- Provide quality input during supplier selection and due diligence processes.
Your Qualifications:
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, or a related field (advanced degree is a plus).
- 3-5 years of experience in pharmaceutical quality assurance, with a focus on supplier management.
- Hands-on experience in GMP environments and supplier auditing.
- Familiarity with QMS and supply chain operations.
- Strong organizational and planning skills.
- Ability to work independently and collaboratively in a dynamic environment.
- Commitment to quality, compliance, and continuous improvement.
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you
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