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Senior QC Analyst Athlone Ireland,  

Posted on : 30 June 2017

Project Description

Job title: QC Senior Analyst Location: Roscommon Reporting to: QC Manager/Designee                Principal Duties and Responsibilities:  Accountable and Responsible supervisor / designee activities. Accountable and Responsible for communications/meetings within QC. Accountable and Responsible for sample management and preparation and execution of weekly schedules to meet business needs. Support QC Manager with budget adherence. Liaise / Represent QC at meeting with other departments with regards to QC related involvement/issues. Accountable for Audit preparation/audit readiness (RFT). Accountable and Responsible for successful management of all laboratory Investigations. Hosting and representing QC during audit conditions. Performing of Internal Audits as required. Analysis of QC samples. Review and Approval of QC Documentation (SOP’s, Test Methods, Raw Data, Q.A.R.’s, LIR’s, C.O.A.’s, Artwork and Reports) Manage compliance to GMP/GLP. Management and oversight of Laboratory Activities in designee capacity. Support the lab analysts in troubleshooting issues as they arise. Report weekly/monthly QC KPI’s. Assist in the resolution of any safety issues and implement/enforce of same. Ensure analysts are cross trained to provide maximum flexibility. Liaise with required departments to ensure smooth testing/production throughput. Perform GMP review of logbooks. QC Documentation Management. QC Data Trending. Lead for timely completion of logbook GMP review. Lead and Support the QC Internal Calibration Programme   Performance/ Behaviour must be consistently achieved in the following: GMP/GLP/Housekeeping Compliance Time Keeping and Attendance Health and Safety Compliance Management of Waste Involvement in 5S/Lean activities Active participation in all Audit preparation activities.   Qualifications & experience: Third Level qualification in a scientific discipline 3-5 Years Work Experience   The role demands a well-organised approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.   Other Information: Full-time, permanent role Although the above is a description of the requirements of the role, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.   Develop and maintain familiarity with applicable legislating, guidelines and current industry practice that impact GMP, GDP and Regulatory Affairs.   Please note that all Athlone Laboratories staff work within a quality management system and that all of the above will apply to the product portfolio .   ATHLONE LABORATORIES IS AN EQUAL OPPORTUNITY EMPLOYER  



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