Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.
A full-time opportunity has arisen at Valneva Scotland for a QC Coordinator (Raw Materials).
We are looking for a positive and enthusiastic individual with a continuous improvement mind set to join and contribute to the QC team whilst maintaining compliance with our Quality Management System.
Out of hours working and/or overtime may be required due to business needs.
- Co-ordinate the testing and release of Raw Materials, ensuring uninterrupted supply of materials to Manufacturing and QC for the JEV manufacturing process.
- Maintain raw material specifications to ensure continued compliance with current pharmacopoeias (e.g. Ph.Eur., USP)
- Apply best GMP work-practices and techniques to sampling
- Support the QC coordinator in performing shipments to subcontractors and other Valneva sites
- Support co-ordination of the storage of QC reference samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
- Support co-ordination of sample logistics for all testing, applying best cGMP work-practices and techniques to sampling and management for the release of raw materials ensuring continuous availability of materials into manufacturing and QC to meet production forecast
- Progress QMS to ensure on time delivery and compliance within the QC department
- Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager
- Maintain all QC systems, databases, logs and support the generation of QC trend data
- Be accountable for the QC areas being clean, tidy and well-organised and in a state of continuous inspection readiness
- Perform routine housekeeping activities in QC including cleaning of equipment and laboratory areas
- Ensure that all required training is complete in procedures performed and operate in compliance with best cGMP working practices at all times
- Support QC activities in line with manufacturing schedule, as per rota (including provision of overtime cover as required)
- Shift work and out of hours work as required
- Identify continuous improvement opportunities and liaise with QC line management (or other functions) to agree benefits and deployment plans
- To undertake any other duties as requested by the line manager in accordance with company requirements
- Actively contribute to the development of the QC Logistics team, for example, through team meetings
- Degree in chemical/biological sciences or relevant experience
- Knowledge of usage of Pharmacopoeias
- Knowledge of GMP guidelines and regulatory bodies
- Experience in method validation / verification is beneficial but not essential
- Experience of Quality Management Systems
- Experience in working with Microsoft Excel, and ERP systems
- Experience of working to deadlines and managing conflicting priorities
- Experience working effectively in a team, influencing as appropriate
- Attention to detail
- Excellent organisational skills
- Effective communication skills
- Flexible and adaptable team player
- Ability to think analytically