Qualified Person - QP
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.
Are you an experienced QP ? Or just starting out on your journey, with a good understanding and working knowledge of the Pharmaceutical Industry we would welcome an opportunity to speak with you further.
With responsibility for performing the legal and routine duties with respect to the review, approval and certification of licensed and investigational products. To maintain effective quality oversight of internal and external contract manufacturing and testing activities in order to verify that local and Global Quality Systems/procedures are defined, being adhered to, are operating effectively and comply with UK, EU, FDA, RoW regulatory requirements.
Our successful Qualified Person would be someone possessing relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment.
- To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed and investigational products; as defined in article 51 of Directive 2001/83/EC (as amended by Directive 2004/27/EC) and described in Annex 16 of the EU Guide to GMP
- To represent the company to external authorities on liaison with MHRA, FDA, EMEA CAs and OMCLs on; product defect reporting, recall and Inspection related matters (all interactions must be aligned with Regulatory Affairs)
- To advise the Director of Quality Operations on any matters arising which impact on supplier or service provider status or 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 subject to temperature excursions and communicate to customers
- To ensure the systems and processes for the management of Product Technical Complaints and Product Recalls are being conducted in accordance with the licensed risk management and pharmacovigilance systems
- To act as Livingston site representative for Product Safety Review Board. Escalation of relevant issues to and from committee meetings/Global Quality Focus Groups
- To assist with the preparation, review and approval of technical / quality agreements for suppliers and service providers
- To prepare and / or review and approve Quality Investigations which impact on cGMP related activities and batch disposition decisions
- In compliance with UK, EU/FDA quality rules and guidelines, to manage the resources, procedures and reports necessary to ensure effective execution of the external supplier audit program to a defined schedule, in conjunction with Global Quality Assurance
- In conjunction with QA, to perform external audits and internal audits as deemed necessary (e.g. for-cause investigations and unscheduled cGMP audits). Provide support to management during third-party audits
- To independently verify the audit reports and programme compliance, escalate any adverse trends or major non-conformances reported and make recommendations on appropriate corrective action in support of the approval / rejection of suppliers or products
- To identify areas of improvement for internal and Global Quality Systems/procedures and to provide support with the implementation of such improvements
- In conjunction with the concerned departmental personnel, develop suitable reporting mechanisms (e.g. key quality indicators) which provide assurance of effective quality oversight of both internal and externally contracted manufacturing and testing activities
- To keep up to date with current guidelines and regulatory requirements (e.g. Pharmacopoeial changes) in respect of quality requirements
- Implement and maintain Standard Operating Procedures, as required
- To undertake any other duties as requested by the line manager in accordance with company requirements
- Degree level education or equivalent experience
- Eligible QP (UK qualified, under the Permanent Provisions)
- Relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment
- Good understanding and working knowledge of the Pharmaceutical Industry