Driven to uphold the highest standards in the pharmaceutical industry? Step into this role where your expertise ensures the delivery of safe, effective treatments worldwide.
Proclinical is seeking a Quality Associate to support third-party quality operations within the EEM-EMEA region. In this role, you will ensure that third-party products meet quality standards and regulatory requirements. You will also maintain and operate quality systems to monitor compliance of external manufacturers and their products. This position offers an opportunity to contribute to quality assurance processes in a dynamic and collaborative environment.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Oversee quality assurance for assigned external suppliers and third-party manufacturers, ensuring compliance with quality standards and legal requirements.
- Monitor third-party performance metrics (KPIs) and promptly report any compliance risks to QA management.
- Review and assess customer complaints, including root cause investigations, product impact assessments, and corrective action plans (CAPA).
- Evaluate third-party deviation reports for accuracy, completeness, and proposed CAPAs.
- Review batch release documentation from third parties to support product shipment and update material status in SAP.
- Analyze Product Quality Reviews (PQRs) for trends and recommend corrective actions, providing summaries to the QA Manager.
- Ensure timely collection of annual pharmacovigilance statements for PQRs.
- Maintain QA systems for external suppliers, including quality agreements, supplier risk assessments, and PQR expectations.
- Provide QA support for projects and expert teams as assigned.
- Represent the quality function within the organization and assist QA management with quality-related matters.
Key Skills and Requirements:
- Degree in Chemistry, Biology, Pharmacy, Pharmaceutical Engineering, or a related scientific field.
- Experience in quality operations within a GMP-regulated environment.
- Strong understanding of regulatory requirements and quality assurance systems.
- Proficiency in office tools such as Word, Excel, and SAP.
- Excellent command of English; additional languages are a plus.
- Experience in handling customer complaints and negotiating QA contracts.
- Familiarity with QA systems supporting third-party management.
- Previous experience working in a global organization is advantageous.
If you are having difficulty in applying or if you have any questions, please contact Dean Fisher at d.fisher@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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