Documentation Specialist

Summary:
Our client, a biopharmaceutical company located in Dublin, is looking for a Documentation Specialist. The successful candidate will be supporting the downstream operations team and be responsible for the timely, accurate and efficient management of documents including access and revision control.

Responsibilities:

• Manage “Live” Documentation updates from the Operations floor.
• Turnaround and issue documentation as per Operations Schedule.
• Manage and implement on the floor documentation control system.
• Drive the Documentation Life Cycle System to ensure documents are approved in as per Scheduling requirements.
• Work with various Subject Matter Experts to ensure technical documentation updates are approved.
• Creation and revision of Standard operating Procedures (SOPs) and Work Instructions (WI’s) as required.
• Work closely with QA, Supply chain and Operations core functions.
• Ensure compliance with all regulatory GMP, Safety and Environmental requirements.

Qualifications & Experience:

• Minimum level 6 in a relevant Qualification.
• Experience working in a Pharmaceutical GMP regulated industry desirable.
• Experience working with GMP Documentation Management Systems.
• Proficient in Microsoft Office Tools (Word/Excel/PowerPoint).