Documentation Specialist

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

He/She will contribute to the High Performance culture within Technical Operations providing a flexible, accurate service to enable the Technical Operations department to achieve MMD four key priorities.

The Documentation Specialist is an active member of the Technical Operations Team, providing support, guidance and expertise to ensure the success of the department

Primary activities/responsibilities:

• Updating of procedural documents
• Preparation of Change Management documentation;
• Processing of documentation through the Change Management System;
• Generation and control of protocols and memos
• Generate Metrics for Technical Operations department
• Coaching others by sharing their skill-set and expertise.

Experiance

• 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 Operations etc).
• 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.

Expected Skills:

• High level technical writing skills
• Demonstrated ability to realize improvement initiatives.
• Demonstrated successes in a team environment, such as project teams.
• Advanced PC skills such as Excel, Word, PowerPoint.
• Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
• Minimum Leaving Certificate with a requirement to advance to a relevant 3^rd Level Qualification (Science, Engineering, Quality, Production) within a three-year period.