Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialise 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.

An opportunity has arisen at Valneva Scotland for a Principal QA Specialist within the Quality Assurance Department to support our team in Livingston.

Job Summary

To provide quality technical expertise for the development, optimisation and introduction of quality management processes associated to manufacturing site operations for existing and proposed new products.  To define, develop and deliver implementation of improvement quality projects for robustness, consistency, success and enhanced outputs.

Responsibilities

  • Act as main support to quality assurance management team including the Head of Quality Assurance and Head of Quality Operations assuming responsibility for reporting status position, providing updates on departmental activities and risks
  • Deputise for the line manager (Head of Quality Assurance) and team colleagues as required, and ensure owned tasks are assigned deputies in their absence
  • Provide and support the leadership of the quality management team during third-party audits
  • Monitor, improve and maintain quality management procedures to ensure compliance with EU / FDA Good Manufacturing / Distribution Practice as well as other appropriate regulatory authorities for the manufacture and testing of pharmaceuticals
  • Lead, co-ordinate and support all quality management systems in accordance with relevant Standard Operating Procedures, including but not limited to:
    • CAPA
    • Change requests
    • Deviations (including Quality Investigations and OOS)
    • Complaints (customer / supplier)
    • Development Studies / Reports
    • Risk Management
    • QMS data logs
    • Room Release documentation
    • Batch record review (including PPRs, PTRs, MPRs, SPRs)
    • Supplier Assurance processes (including external audits)
    • Validation
  • Progress department QMS activities to agreed timelines
  • Be accountable for on time document management and performance measurement
  • Lead and support the delivery of key quality metrics for the Quality Management Systems ensuring such metrics are available to management to drive continuous improvement and compliance with current regulations, quality requirements and Valneva business needs. Presentation of key Quality Metrics to the Site monthly QRB
  • Lead and assume responsibility for trending and reporting on batch review/release process and quality management system data
  • Utilise critical quality management trended data to support site management of changes. Additionally analyse key critical quality data for the identification and mitigation of process risks or failure mechanisms through trending and escalation
  • Act as main site wide quality expert including being key role in troubleshooting and lead key technical investigations, risk assessment, change management and site projects
  • Provide principal quality assurance support and leadership in the implement of site project activities which will support the commercial manufacturing process
  • Identify and lead the delivery of quality improvement projects, from conception to implementation, with a view to increased quality robustness and oversight to support site commercial manufacturing activities
  • Perform training of staff within the quality assurance department, across the site and between sites in areas of expertise where required
  • Actively contribute to the development, maintenance, support and collaborative of an effective working environment within the quality assurance team, across the site and between sites
  • To deputise where appropriate and undertake any other reasonable duties as requested by the Head of Quality Assurance, in accordance with company requirements
  • Shift work and out of hours work as required

Experience

  • Experience of working within a GMP / GDP manufacturing environment
  • Experience of working within MHRA / EU / FDA accredited facilities
  • Previous experience of working to tight deadlines and re-prioritising workload
  • Proven experience of working with operational excellence improvement tools
  • Experience of leading and delivering quality metrics

Required Skills

  • Strong attention to detail
  • Clear and effective communication skills
  • A logical approach to problem solving
  • Pro-active self-starter with ability to engage and motivate others
  • Proven ability to manage own workload
  • Ability to analyse and interpret quality data
  • Multi-tasker with ability to work to changing priorities
  • Ability to work to own initiative and successfully contribute as part of a team

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