An exciting new opportunity has arisen for a QA Specialist (Manufacturing Execution System) with a top company in Limerick. The successful candidate will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with QA policies and procedures, cGMPs, SOPs, and the companies standard required documents.
Role of this position
- You will represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
- You will be involved with training and/or mentor junior employees, including providing insights and education on processes and procedures.
- You will perform activities associated with disposition of raw materials and product (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk
- You will review, edit, or approve controlled documents and investigations associated with raw materials, product, laboratory, facilities, and materials.
You will be involved with continually evaluating processes and procedures with an eye toward continuous improvement.
- You will work directly with the MES and Operations teams in the design and development of electronic Master Batch Records and Equipment Specifications for site processes/products.
You will perform activities associated with the approval of design specifications, electronic Master Batch Records and MBR Testing.
- You will be involved with reviewing and approval of procedures associated with the Manufacturing Execution System.
- BS/BA in scientific discipline or related field essential.
- Mnimum of 2 years relevant experience essential.
- MS/MA in scientific discipline or related field advantageous, however, relevant experience may be substituted for the MS/MA requirement.
- Experience with Manufacturing MES Systems very advantageous.
- Understanding of biologics manufacturing operations is preferred.
Please contact Michelle Galvin today for further information on 091 373938 or email mgalvinATcareerwiseDOTie
CareerWise Recruitment (In Search of Excellence)