QC Specialist (Equipment)

The specialist will manage the purchase and qualification of laboratory instruments and will be responsible for supporting equipment maintenance and calibration support. The candidate must have strong experience in all aspects of instrument management in a GMP environment, in addition to an understanding of the needs and best practices of routine biopharmaceutical drug substance laboratories. They will have responsibility for establishment of project plans and instrument qualification procedures. Experience in Data Integrity management (21 CFR 11 / EU Annex 11) is desired. A strong fundamental understanding of QCL equipment expertise is desirable and Biopharmaceutical analytical platforms (HPLC / UPLC, CE, cIEF, Mass Spec, Platereaders, Liquid Handlers). Responsibilities will include. Supporting a Calibration and / or Maintenance Service to the QC laboratory that relating to instrument maintenance and instrument lifecycle management. Review and approve analytical instrumentation qualification, calibration, repairs and documentation. Ensure instrument maintenance and verification is appropriate to the use of the instrument Manage all instrument specific investigations such as calibration deviations Trend lab instrument performance and lifecycle management. Participate in new instrument purchase and qualification Participate as part of a team of QC Specialists, QA Specialists and Computer System Validation personnel to deliver on the qualification of new instruments. Liaise with sister sites and vendors on instrumentation purchase, qualification and lifecycle management. Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management and ensuring audit readiness for equipment related processes and documentation Participate in definition and establishment of instrument related procedures. Participate in troubleshooting complex instrumentation issues. Qualification & Experience : B. Sc. in scientific related discipline Must have at least 3 year's industry experience within a biopharmaceutical / pharmaceutical QC lab At least 1 years experience should be related to instrument qualification experience in a GMP laboratory setting. Experience with connected equipment and digital systems would be advantageous. The successful candidate must demonstrate the ability to contribute to and lead in a team based collaborative environment, as well as the ability to prioritise objectives from multiple projects. The successful candidate must demonstrate time management, and organisational skills and excellent communication is essential. Skills : calibration Annex 11 Laboratory Equipment GMP