Job Description: QA Specialist
We are a specialty vaccine company dedicated to developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs.
Our expertise has enabled us to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to advance a broad range of vaccine candidates into and through clinical development, including candidates against Lyme disease and Zika.
With operations in Austria, Canada, France, Sweden, the United Kingdom, and other locations, we are committed to making a positive impact on global public health.
We value diversity and inclusivity, making Valneva a great place to work for people of all backgrounds.
Our Quality Assurance team is seeking a QA Specialist to assist in developing and maintaining a comprehensive pharmaceutical quality management system, ensuring regulatory compliance, product quality, and inspection readiness.
Responsibilities
* Maintain an effective and compliant Supplier Quality Management system aligned with regulatory requirements (GDP, cGMP, FDA, MHRA, WHO, PIC/S) across sites.
* Plan and track supplier-related activities to meet timelines and targets.
* Collaborate internally and externally to enhance regulatory compliance, service quality, and project efficiency.
* Conduct qualification and re-qualification activities for GxP impacting suppliers, materials, and services.
* Monitor supplier performance with Procurement and Supply Chain teams.
* Prepare and review Quality/Technical Agreements.
* Lead risk-based preparation, execution, and monitoring of external audits.
* Maintain the Approved Suppliers List/Registry.
Additional Activities
* Manage documentation in line with SOPs, including GxP documentation and archiving.
* Support continuous improvement initiatives, including digitalization of GxP systems.
* Develop and present key quality metrics to support governance meetings.
* Deliver quality training as needed.
* Review and assess CAPAs, perform effectiveness checks.
* Conduct risk assessments and verify mitigations.
* Review change controls and monitor progress and effectiveness.
* Investigate quality events and escalate as necessary.
* Support internal and external audits, ensuring data integrity and compliance.
Qualifications and Experience
* Graduate degree in Biology, Chemistry, Pharmaceutics, Biotechnology, Biochemistry, Pharmacy, or related field.
* Preferably 3+ years’ experience with UK, EU, FDA, or WHO cGMP/GDP requirements.
* Experience in quality management systems, continuous improvement, and audit leadership.
Skills
* Attention to detail and focus.
* Effective communication skills in English.
* Proficiency in MS Office and eQMS software (e.g., Smartsolve, Trackwise).
* Problem-solving with a logical, methodical approach.
* Proactive, resilient, and able to work independently and on multiple projects.
Please note that a valid work permit may be required if you are not a passport holder of the country for this vacancy. For more information, visit our Blog.
Applications should be submitted via the 'Apply now' button. Do not include bank or payment details in your application.
Created on 28/04/2025 by TN United Kingdom
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