Job Description
This is an 11-month contract and is a fully onsite position. Purpose Responsible for generating and expediting review and approval processes for QC GMP documentation including but not limited to Quality Notifications, Laboratory Investigations, CAPAs, Effectiveness Checks, Standard Operating Procedures, Standard Work Instructions and change controls, Annual Product Reviews, Trend Reports, Out of Process Control Limit events, Compendial Assessments. Author/ Provide technical expertise and technical oversight of the above QC documentation. Ensure that objectives are effectively achieved, consistent with Company requirements to ensure compliance, safety, and reliable supply to our customers.) Responsibilities Support Quality Control activities in the QO laboratory through documentation generation and investigations associated with GMP activities. Author/ Provide technical expertise and technical oversight of Investigations, Quality Notification, Out of Process Control Limit OOPCL completion, Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, and change controls. Support Laboratory activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system. Support Batch release through timely Investigations, Quality Notification, Out of Process Control Limit OOPCL completion,Interim/summary report generation; meeting batch release requirements. Perform Compendial Assessments. Author Annual Product Review, Trend Reports. Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 whys etc.; implement subsequent corrective action through the change management system. Required to comply withQ Global Policies, Procedures and Guidelines,regulatory requirements and execute current Good manufacturing Practices (cGMP)in the performance of day to day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Assist in the management and/or assignment of QC training if required Requirements Bachelors Degree or higher preferred; ideally in a Science, or other Technical discipline Relevant experience in QC Laboratory within GMP setting Proficiency in Microsoft Office and job related computer applications required with proven analytical and systematic problem solving skills Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required Analytical Method validation Strong influencing skills Flexible approach Effective time management and multi-tasking skills Proven organizational skills Excellent attention to detail Skills: Documentation Generation Lab Investigations CAPAs QC Lab GMP