IRE_Quality Operations Technician

We are looking for a Quality technician to join our Dundalk Team. (Monday to Wednesday nights.)

Responsibilities

Generate Packaging Instructions, Batch Packaging Records and labels for use in production from Master documents; Perform AQLs as required during production operations; Sampling, approval and release incoming goods, packaging materials and product (where required) for use in production; Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product from customers/suppliers; Review and filing of stock cards, approval forms, equipment LUMAC logs and other production logbooks; Identify training needs in conjunction with the production manager and conduct staff training as required; Assist with environmental monitoring procedures, update spreadsheets to facilitate trending of results; Ad-hoc checks, in-process checks and documentation review on a routine basis on production lines; Approval of Line clearance procedures; Approval of Pre-production samples; Maintenance of batch documents and retain samples in archive; Update the PQR database after QP release; Liaise with customers/suppliers for artwork related queries and management of approval of artwork; Raise Deviations, Corrective Action Requests, Non-Conformance reports as required and in a timely manner and ensure issues are communicated to the QC Manager/designee; Ensure activities observed are in compliance with the requirements of cGMP; Assist in performing validation studies; Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health & Safety meetings; Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

Requirements

Degree and/or relevant experience