QC Chemistry Analyst

IrishJobs

Dublin, Dublin, Ireland

Dublin, Dublin, Ireland

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Description: The individual in this position should have a working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with Chemistry analysis. The QC Chemistry Review Analyst is responsible for performing high-quality, timely review of QC laboratory documentation to ensure data integrity, regulatory compliance, and adherence to internal SOPs. The documentation reviewer will assess raw data, analytical results, chromatography data, calculations, instrument printouts, and electronic records for completeness, accuracy, ALCOA principles, and traceability; verify that methods and specifications are correctly applied; confirm proper approvals and contemporaneous documentation; and identify, triage, and help resolve discrepancies or errors through deviation and CAPA processes. The individual will collaborate closely with analysts, to clarify data, drive right-first-time execution, and support batch release and stability program timelines. The individual must be able to perform routine tasks with a minimum of supervision You will be responsible for: Ensuring high cGMP, GLP standards are maintained while reviewing and adherence to schedules and targets to meet regulatory and business requirements. Represent the Chemistry department in internal and external audits where appropriate. Close out of actions/ recommendations identified from both internal and external audits. Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate. To maintain competence and keep up to date with all new technologies, procedures and methods used in the Chemistry Laboratory. Perform technical review of data generated in laboratory, validation protocols and reports. Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required. To ensure a high standard of housekeeping and safety is maintained in the Laboratory. Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department. To keep management updated on issues arising within the laboratory. Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Chemistry Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time. To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs. You will need to have Minimum of 2 year s experience in cGMP Quality environment. Experience in Empower Chromatography Software Good knowledge of current regulatory requirements for cGMP operations supporting clinical and commercial manufacturing. Good understanding of Data Integrity Principles in Practice. Degree in Chemistry or related science. We would prefer for you to have: Experience in Data Review in a GMP Quality Environment. Experience in Compendial Chemistry Assays. Experience in HPLC & UPLC. Skills: GMP QC Laboratory Environment QC Chemistry Review Analyst

TLNT1_IJ

Dublin, Dublin, Ireland

Sprachkenntnisse

English

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