An opportunity has arisen at Valneva Scotland Ltd for a Qualified Person.
Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs, with a sterile vaccine manufacturing facility near Edinburgh. This opportunity comes at a very exciting time in the lifecycle of the site and the Company.
The role is site-based with the responsibility of overseeing quality of both commercial manufacturing and the multi-product IMP facility cleanrooms and the associated processes, ideally on a full time, permanent basis.
The ideal candidate will be qualified as a QP under the permanent provisions, preferably with previous biological products experience and ready to be named on the MIA. A biology qualification or equivalent with a minimum of sterile dosage form manufacturing and release experience are required. Experience in a vaccine production environment would be a strong advantage.
The ideal candidate would also demonstrate the following competencies:
- Proven ability to make confident decisions based upon sound justification
- Proven ability to apply problem solving skills to a wide range of issues while maintaining a positive attitude towards those involved
- Proven ability to manage multiple tasks simultaneously whilst maintaining a high level of accuracy in all work carried out
- Demonstrable ability to adapt to change and implement change accordingly
- To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed and investigational products; to represent the company to external authorities on liaison with MHRA, FDA and OMCLs on; product defect reporting, recall and Inspection related matters
- To advise the Director of Quality Operations/Site Director/Corporate Bodies on any matters arising which impact on supplier or service provider status, the import of bulk product into EU, or release of final product for use in the UK/EU and its export from the EU
- To manage the batch disposition process, comprising batch document review and approval and batch certification file compilation. Make quality assessments on released products subjected to temperature excursions, Product Technical Complaints, etc. and communicate to customers
- Maintain oversight of Valneva’s Quality Management System, including implementation and maintenance of Standard Operating Procedures, as required. To prepare and/or review and approve Quality Investigations which impact on cGMP related activities and batch disposition decisions. To identify areas of improvement for internal and Global Quality Systems/procedures and to provide support with the implementation of such improvements
Find out more about Valneva at www.valneva.com
If you feel this role is a fit for your skills and attributes and would like to further discuss how well Valneva’s Quality Culture suits you and vice versa, or to simply apply, please send an e-mail and your CV to LIV-HR@valneva.com and we will get in contact with you.