Valneva Livingston, Scotland, United Kingdom
Valneva Livingston, Scotland, United Kingdom
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We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.
With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.
Together, we are a global Company which is open topeople of all backgrounds.Our diverse and inclusive workforce makes Valneva a great place to work.
Our QC Team have an exciting new opportunity to support with Sample management, liaising with external test houses for our Sample management. read on to find more details on this great opportunity.
Job Summary
To execute and co-ordinate laboratory support activities within the Quality Control Department in accordance with defined procedures, protocols and regulatory guidelines.
Responsibilities
* To execute and co-ordinate laboratory support activities including raw material sampling and release, stability sampling and sample management in a timely manner.
* Maintain raw material specifications to ensure continued compliance with current pharmacopoeias (e.g. Ph. Eur., USP)
* Execute and co-ordinate on time delivery of Quality Control documentation required for raw material or finished product batch release and maintain GMP documentation, e.g. review and archiving
* Co-ordinate and execute the storage of QC samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
* Support the purchasing and introduction of equipment (including their maintenance and calibration) required to adequately support routine laboratory activities
* Liaise with external sub-contractors to-ordinate on time testing by external test houses and ensure timely review of external CoA's, escalating and raising external QMS as required in the event of a supplier non-conformance or notification
* Maintain all QC systems, databases, logs and support the generation of QC trend data
* Initiation of QMS documentation within the allocated timeframes
* Be accountable for the QC laboratories being clean, tidy, well organised and in a continuous state of audit readiness
* Contribute to an independent safety culture, ensuring that EOHS requirements are adhered to, including individual training, and that any incidents are reported in a timely manner to the Head of Quality Control and the EOHS department.
* Ensure appropriate training for tasks is current 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 Manager.
* Ensure the principles of Data Integrity are deployed and that issues are escalated to the Manager 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 and drive a culture of continuous improvement and process efficiencies within areas of responsibility
* Be responsible for working with your manager to identify development activities.
* Other tasks required by the department to support other QC functions
* Shift work and out of hours work as required
* Undertake any other duties in accordance with company requirements
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.
With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.
Together, we are a global Company which is open topeople of all backgrounds.Our diverse and inclusive workforce makes Valneva a great place to work.
Our QC Team have an exciting new opportunity to support with Sample management, liaising with external test houses for our Sample management. read on to find more details on this great opportunity.
Job Summary
To execute and co-ordinate laboratory support activities within the Quality Control Department in accordance with defined procedures, protocols and regulatory guidelines.
Responsibilities
* To execute and co-ordinate laboratory support activities including raw material sampling and release, stability sampling and sample management in a timely manner.
* Maintain raw material specifications to ensure continued compliance with current pharmacopoeias (e.g. Ph. Eur., USP)
* Execute and co-ordinate on time delivery of Quality Control documentation required for raw material or finished product batch release and maintain GMP documentation, e.g. review and archiving
* Co-ordinate and execute the storage of QC samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
* Support the purchasing and introduction of equipment (including their maintenance and calibration) required to adequately support routine laboratory activities
* Liaise with external sub-contractors to-ordinate on time testing by external test houses and ensure timely review of external CoA's, escalating and raising external QMS as required in the event of a supplier non-conformance or notification
* Maintain all QC systems, databases, logs and support the generation of QC trend data
* Initiation of QMS documentation within the allocated timeframes
* Be accountable for the QC laboratories being clean, tidy, well organised and in a continuous state of audit readiness
* Contribute to an independent safety culture, ensuring that EOHS requirements are adhered to, including individual training, and that any incidents are reported in a timely manner to the Head of Quality Control and the EOHS department.
* Ensure appropriate training for tasks is current 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 Manager.
* Ensure the principles of Data Integrity are deployed and that issues are escalated to the Manager 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 and drive a culture of continuous improvement and process efficiencies within areas of responsibility
* Be responsible for working with your manager to identify development activities.
* Other tasks required by the department to support other QC functions
* Shift work and out of hours work as required
* Undertake any other duties in accordance with company requirements
Requirements
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
Required Skills:
·Ability to work within a busy QC laboratory and warehouse setting
·Be motivated and forward thinking
·Ability to work well in a team
·Flexible and able to efficiently adapt to organisational changes
·Ability to utilise resources to solve problems
·Strong attention to detail
Benefits
* Stock Options
* Employee Assistance Programme
* Gym membership OR fitness allowance
* LinkedIn Learning
* Many others included
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Other
* Industries
Non-profit Organizations and Primary and Secondary Education
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