The Documentation Specialist is accountable for the smooth execution of all appropriate documentation associated within QA. They will contribute to the High Performance culture within the Quality Team by providing a flexible, accurate service to enable them to achieve key priorities.
The Documentation Specialist is an active member of the cross functional QA Team, providing support, guidance and expertise to ensure the success of the Quality Department.
Duties and Responsibilities:
Updating of procedural documents;
Preparation of change control documentation;
Processing of documentation through the Change Control System;
Review of batch records and recording of incidences of corrections made to batch records;
Generation and control of protocols.
Minimum Leaving Certificate with a requirement to advance to a relevant 3rd Level Qualification (Science, Engineering, Quality, Production) within a three year period.
At least three years experience in the Pharmaceutical industry or a similar operating environment.
Knowledge of and experience in applying Lean Six Sigma and Lean methodologies.
For a confidential discussion and more information on the role, please contact Rory Walsh.