Are you passionate about quality and precision? Join our client in this Quality Assurance Representative and help ensure top-tier standards every day.
Proclinical is seeking a Quality Assurance Representative to support third-party quality operations and ensure that products are manufactured and released in compliance with regulatory standards and internal requirements. This role focuses on maintaining robust quality systems, overseeing external suppliers, and ensuring adherence to established processes.
Responsibilities:
- Provide quality assurance oversight for external suppliers and third-party manufacturers to ensure compliance with quality standards and legal requirements.
- Monitor supplier performance metrics (KPIs) and report any compliance risks to QA management.
- Review and assess customer complaints, including root cause investigations, product impact evaluations, and corrective action plans.
- Evaluate third-party deviation reports for accuracy, completeness, and compliance, including trending and recurrence analysis.
- Review batch release documentation from third parties and manage material status changes in SAP.
- Analyze Third Party Product Quality Reviews (PQRs) for trends and recommend corrective actions.
- Ensure timely submission of annual pharmacovigilance statements for PQRs.
- Maintain and utilize QA systems for supplier oversight, including updating quality agreements, performing risk assessments, and ensuring PQR compliance.
- Support QA management in addressing quality-related matters and participate in assigned projects or expert teams.
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 systems.
- Proficiency in office tools such as Word, Excel, and SAP.
- Excellent command of English; additional language skills are a plus.
- Preferred experience in customer complaint handling, negotiating QA contracts, and managing QA systems for third-party oversight.
- Familiarity with working in a global organization is advantageous.
If you are having difficulty in applying or if you have any questions, please contact Harry Budge at h.budge@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.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy.
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