Job Category: Quality Control

Valneva is a speciality 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 750 employees.

Job Summary

To undertake microbiological tasks and analysis for the release and monitoring of facilities, raw materials, intermediate and final product samples according to defined procedures and protocols, in accordance with regulatory requirements.

Responsibilities:

• Execute microbiological procedures for testing of raw materials, intermediate products and final product samples, according to defined SOPs and protocols
• Perform environmental monitoring of cleanroom areas as required, to support manufacturing processes and Facility Contamination Control (FCC)
• Conduct all activities in a careful and safe manner and in full compliance with HSE requirements
• Ensure that all required training is complete in procedures performed and operate in compliance with regulatory requirements
• Adhere to 5S working practices. Identify and implement areas for continuous improvement and escalate to Line Manager
• 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 QC areas being clean, tidy and well organised and in a state of continuous inspection readiness
• Ensure that equipment, facilities and materials used in the QC laboratories comply with defined standards
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
• Undertake any other duties in accordance with company requirements
• Undertake shift work and/or support activities that require to be performed out of normal business hours, when requested, to support business priorities

Experience:

• Degree in biological sciences or relevant experience
• Knowledge of GMP guidelines and regulatory body requirements
• Experience of microbiological methods in a production-focused environment including but not limited to; Total Viable Count, Bacterial Endotoxin, Environmental monitoring, Microbial Identification and Growth Promotion
• Minimum of 1 Year relevant Industry Experience
• Biologics / vaccine background ideal
• Experience of Quality Management Systems
• Experience of working to deadlines and managing conflicting priorities
• Experience managing external relationships for effective delivery, e.g. vendors, test houses

Skills:

• Ability to organise, deliver planned schedules and work across QC, Process Development and QA
• Experience of writing QMS documentation, e.g. SOPs, Deviations, Change Controls, CAPA desired
• Excellent time management and prioritisation skills
• Ability to communicate at all levels within and outside QC
• Ability to contribute effectively to successful teamwork, and work independently and manage own workload when required

Valneva is a speciality 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.

An opportunity has arisen for a QC Lab Manager (Micro) to join our team in Livingston based team on a 12 month fixed term contract.

Job Summary

To provide oversight and co-ordinate the routine running of the QC Microbiology. Provide technical expertise and guidance to support Sterility Assurance, Microbiology and Facility Contamination Control (FCC) initiatives on site.

Responsibilities

• Ensure that EOHS requirements are met by the team, including individual/team training, and that any incidents are investigated and reported in a timely manner to the Head of Quality Control and the EOHS department.
• To manage Microbiology activities in support of manufacturing schedules and support FCC activities
• Oversee the execution of microbiology activities according to defined SOPs and protocols with timely reporting of issues to relevant staff
• Provide support as Subject Matter Expert (SME) in microbiologically related investigations and other problem solving forums
• Maintain knowledge and competence to undertake tasks within the team, for example, at times of absence or high workload
• Ensure testing in the microbiology laboratories is scheduled and performed in a timely manner and in alignment with the Manufacturing Master Planning Schedule
• Manage and maintain facilities, resources and equipment required to adequately support microbiology activities
• Ensure direct reports are appropriately trained and competent in the procedures they are conducting, and are in compliance with cGMP working practices at all times
• Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of Quality Control, Head of Facility Contamination Control (FCC) and Qualified Person (QP)
• Manage and co-ordinate on time delivery of QMS documentation by the team
• Ensure the principles of Data Integrity are deployed within the team and that issues are escalated to the Head of Quality Control in a timely manner
• Ensure high standards of housekeeping are maintained within areas of responsibility
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative team within QC
• Develop, collate and report key quality/business related metrics, and use such metrics to drive a culture of continuous improvement and process efficiencies within areas of responsibility
• Contribute, encourage and support staff development activities
• To undertake any other duties as requested by the line manager in accordance with company requirements
• Support shift and out of normal hours work, including weekends, as required to support business requirements
• Deputise for the Head of QC during times of absence or a need for technical expertise

Experience

• Educated to degree level or equivalent experience
• Experience within a QC Laboratory working to GMP within a recognised quality system (3+ years)
• Knowledge of GMP guidelines and regulatory bodies
• Previous supervisory experience in a lab environment preferred

Required Skills

• Ability to lead and co-ordinate work within a busy QC laboratory
• Ability to motivate and engage an effective workforce
• Ability to develop and manage change projects effectively and efficiently
• Effective communication and presentation skills (for internal and external interactions)

Valneva is a speciality 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 750 employees.

Summary

To execute defined and trained Quality Control department tests for the release of raw materials, intermediate products and final products according to defined procedures and protocols and according to best cGMP work practices, Quality Standards and metrics, as well as assisting in the implementation and maintenance of policies for Quality Control department within Valneva. Carry out laboratory tasks as identified by QC department.

Responsibilities

• Inspection and labelling of Incoming Goods
• Maintain raw material specifications to ensure continued compliance with current pharmacopoeias (e.g. Ph.Eur., USP)
• Support / co-ordinate the testing and release of raw materials, ensuring uninterrupted supply of materials to Manufacturing and QC for the manufacturing process
• Apply best GMP work-practices and techniques to sampling
• 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
• Prepare and submit Purchase Orders for raw material external testing
• 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
• Act as departmental point of contact on relevant site projects
• Support other QC activities in line with the manufacturing schedule

Experience

• Degree / HND / HNC in chemical/biological sciences or relevant experience
• Knowledge of usage of Pharmacopoeias is beneficial but not essential
• 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

Skills

• Attention to detail
• Excellent organisational skills
• Effective communication skills
• Flexible and adaptable team player
• Ability to think analytically