The Documentation Specialist is accountable for the smooth execution of all appropriate documentation associated with 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.