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The successful candidate will be responsible for leading the effective and efficient running of Analytical Bioassay and ELISA methodologies both globally and locally, Analytical Method Transfers, Validations, Investigations and Change Control. In addition, the successful candidate will be a member of the Analytical Sciences Leadership team governing the Analytical Sciences group.
Document maintenance work, including upgrades, made to existing equipment, including preventative maintenance performed and parts used, to ensure appropriate documentation and records of repair history. Operate and monitor production support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs, whilst facilitating continuous process improvements using Lean Principles.
Document maintenance work, including upgrades, made to existing equipment, including preventative maintenance performed and parts used, to ensure appropriate documentation and records of repair history. Operate and monitor production support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs, whilst facilitating continuous process improvements using Lean Principles.
Mechanical assembly of component parts, in sub-assemblies as well as overall machine builds, and pre-delivery testing
The Quality Manager promotes the Quality assurance ethos to be adopted across all projects both internally through communication and training of project staff and externally through attendance at project tender presentations and liaison with vendors as required.
The successful candidate will be responsible for leading the effective and efficient running of Analytical Bioassay and ELISA methodologies both globally and locally, Analytical Method Transfers, Validations, Investigations and Change Control. In addition, the successful candidate will be a member of the Analytical Sciences Leadership team governing the Analytical Sciences group.
The full QC analytical scope will incorporate micro, raw materials, stability, and in-process. Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc.) will allow the candidate challenge current thinking in designing for the future. The candidate will have responsibilities in the qualification of methods.
The External Manufacturing (ExM) Technical Operation organization is seeking a highly motivated individual for a Technical Transfer position. ExM Tech Ops is accountable for technology transfers and commercial production of sterile drug product at our External Partners (EPs). This person will have the opportunity to participate in all these areas.
The Objective of the Quality Control Specialist is to: * To liaise with Quality Management (QM), Production, Engineering, and Administration personnel to validate the different processes carried out. * To liaise with Production, Engineering, and Administration personnel to perform quality controls and inspections.
Work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards.