Chez Valneva, nous sommes fiers de nos succès passés, présents et futurs. Nos réussites sont basées sur la culture du Groupe, fondée sur le respect, l'engagement et la motivation.
Nous sommes Valneva
"Valneva is a fast-paced and versatile workplace, where you can feel the enthusiasm and really move things. Although everyone is very focused, you can easily approach colleagues, even across departmental and hierarchical boundaries."
Klaudia, Head of Commercial Operations en Autriche
"On the Scouting and Innovation team, we are looking for new vaccine candidates that Valneva could bring into its pipeline. As a scientist at Valneva, I am glad that my work allows me to contribute to the prevention of infectious diseases and make a difference in people’s lives."
Melissa, Senior Scientist en France
"It is a pleasure to work with these talented people at Valneva in Sweden for the production of the Company’s cholera vaccine. Although each employee has his or her area of expertise, we also have the possibility to gain an understanding of the entire vaccine life cycle."
Robert, Head of Manufacturing Operations en Suède
"No matter if you work in research, manufacturing, administration or IT, the key to collaboration is a constructive and appreciative dialogue between colleagues. At Valneva, you will find challenging assignments, a multicultural environment, and a clear commitment to ethics, compliance and integrity."
Douglas, Senior Systems Administrator in Scotland
- Contrat: CDI
- Location: Livingston, Scotland
Valneva est une société spécialisée dans les vaccins se concentrant sur la prévention contre les maladies générant d’importants besoins médicaux. Le portefeuille de produits de Valneva inclut deux vaccins du voyageur, IXIARO® /JESPECT® contre l’encéphalite japonaise et DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including unique vaccines against Lyme disease and chikungunya. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with approximately 500 employees.
An opportunity has arisen in Quality Operations at Valneva Scotland for a Qualified Person. This is a new full-time, permanent role.
Job Summary: 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, and are operating effectively within UK, EU, FDA, RoW regulatory requirements and standards.
Ideal Candidate: Qualified under permanent provisions, preferably with biological products experience. A biology qualification or equivalent with a minimum of sterile dosage form manufacturing and release experience. Experience in a vaccine production environment would be a strong advantage.
Key Responsibilities: 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 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, 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 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
- Qualified Person under permanent provisions
- Sterile dosage form experience
- Experienced in batch manufacturing and release
- Ability to manage conflicting priorities and workloads
- Ability to work well on own initiative and under pressure, be able to think ‘outside the box’ well as being able to work well with others
- Biology degree or equivalent
- Biological product/vaccine experience would be an advantage
- Previously named on a Manufacturing Importing Authorisation
Skills and 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
Valneva exerce ses activités depuis l'Autriche, la Suède, le Royaume-Uni, la France, le Canada et les Etats-Unis.
ViennaValneva Austria GmbH
Campus Vienna Biocenter 3
1030 Vienna, Austria T: +43 1 20620 F: +43 1 20 620 800 Nous contacter
3535 Saint-Charles Blvd.,
Kirkland, Québec H9H 5B9
Canada T: +1 514 630 6999 F: +1 514 630 9666 Nous contacter
SolnaValneva Sweden AB
SE – 105 21 Stockholm, Sweden
Gunnar Asplunds allé 16
171 69 Solna, Sweden T: +46 (0)8 735 10 00 F: +46 (0)8 82 73 04
LivingstonValneva Scotland Ltd.
Oakbank Park Road
Livingston EH53 0TG
Scotland T: +44 1506 446 600 F: +44 1506 446 601 Nous contacter
FleetValneva UK Ltd.
Ancells Business Park
Ancells Road / Fleet
Hampshire GU51 2UJ, United Kingdom T: +44 1252 761007
GaithersburgValneva USA, Inc.
910 Clopper Road, Suite 160S
Gaithersburg, MD 20878, USA T: +1 866 223 7118 Nous contacter