QA Support Officer

QA Support Officer- Dublin 15

My client in Dublin 15 is seeking a detail-oriented and organized QA Support Officer to join their Quality Assurance team. This role focuses on ensuring compliance with GMP guidelines through effective management of batch files, samples, and documentation, as well as supporting regulatory and customer audit preparation. The ideal candidate will have experience in a GMP environment, a strong understanding of quality processes, and a proactive approach to maintaining QA systems and records.

Key tasks and responsibilities

·      Logging of batch files, worksheets, AQL and samples into QA and update logbooks in accordance with GMP guidelines.

·      Organisation and maintenance of batch file and sample flow within QA

·      Providing batch files to other departments as required

·      Preparation of manufacturing and packaging batch documentation

·      Updating and maintaining QA trackers for batch release

·      Support shipping requirements

·      Archiving

·      Assisting in preparation for regulatory and customer audits.

·      Other duties as required and as directed by the Sr. Quality Assurance Officer

·      To perform all activities in accordance with current Good Manufacturing Practice.

·      Adhere to the requirements of the Directive 2001183/EC amended by 2004/27/EC and 2003/94/EC and as interpreted in the EC guide to GMP have been followed.

·      To participate in all training and assessment activities. To participate in all SOP training and assessment related to your job.

·      To attend all training courses (internal and external), seminars as required for training related to your job.

·      In conjunction with the QA Manager or designee to ensure all training and assessment is recorded and signed for on your Individual Training Record.

Requirements

·      Associate degree/college diploma I relevant discipline (Level 6)

·      Experience working within GMP environment