The Documentation Specialist will provide compliant, accurate and timely documentation support to the Quality team.

Responsibilities

• 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.
• Will participate and comply with the site Quality Management System (QMS) requirements, including ownership, as relevant to you.
• 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.
• Responsible for supporting a culture of Continuous Improvement by deploying site Six Sigma tools within Quality.
• Coaching others by sharing their skill-set and expertise.

Qualifications & Education

• Demonstrated knowledge of the requirements for entries and completion of batch records.
• Knowledge and experience of GMP and GDP in a pharmaceutical environment.
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, Tech Services etc).
• Experience in the Pharmaceutical industry or a similar operating environment.
• Knowledge of and experience in applying Lean Six Sigma and Lean methodologies.
• Minimum Leaving Certificate with a requirement to advance to a relevant 3rd Level Qualification (Science, Engineering, Quality, Production) within a three year period.
• Desirable: Qualification in a biological science subject.
• Desirable: Evidence of Continuous Personal Development.
• Desirable: Six Sigma Yellow Belt.
• High level technical writing skills

To apply contact Martin Lynch on 087-344 3581.

Email CVs to mlynch@mile.ie