Senior Chemistry/Laboratory Co-Ordinator

ICDS Recruitment

Waterford

Senior Chemistry/Laboratory Co-Ordinator. Senior Chemistry/Laboratory Co-Ordinator within the the QC/QA Laboratory Team. We welcome applications from candidates who have: Degree in Chemistry with 5+ year’s experience in a laboratory environment and in a regulated pharmaceutical/medical device environment. Experience in the use of general laboratory equipment and have a full understanding of the requirements of the Regulatory Standards. Experience of method validation, method transfer, equipment qualification and validation. Familiarity with OOS management, NC and CAPA system required. Good communication skills and High attention to detail. Self-starter, highly motivated with the ability to prioritize. Proven ability to work on own initiative and as part of a cross functional team. Responsiblities include: Co-ordinate and supervise the efficient testing activities within the chemistry laboratory to ensure the timely testing of raw materials, in-process sampling and finish product to ensure that manufacturing schedules are achieved. Involved in laboratory validations to ensure that all test methods are validated to USP and ICH requirements, ensure that the testing procedures are generated for the routine testing of the validated method and involved in the training of analyst to the new validated method. Co-ordinate the testing equipment to ensure that the testing equipment is maintained in good operating condition and within its required calibration frequency. Schedule calibration of equipment if required. Involved in the sourcing and qualification of new equipment, ensuring that the equipment sourced is of the correct accuracy to enable generating of testing data for release of materials. Involved in the generation of NC's, site root cause investigations, process and laboratory pFMEA’s and CAPA activities, if required. Data trending of testing results to ensure that the processes/ vendors are operating within the capability from QC testing criteria, determine if there is an adverse trend and react/ investigate the potential cause of the adverse trend. Manage documentation to ensure that all testing and operating SOP’s are up-to-date and within the required review period. Participate at a technical level in out of specification investigation and non-conformance management. Involved in the laboratory day to day activities to ensure that the laboratory is a safe place to work and is clean to a GMP standard. Participate in improvement activities to ensure the continuous improvement of the laboratory and the activities that are being completed within the area. Stand-in for the laboratory manager. Additional requirements of the job will be specified by the Laboratory Manager. This job originally appeared on RecruitIreland.com.

2802 days ago