Operations Documentation Specialist

Summary:
An Operations Documentation Specialist is required for a biopharmaceutical company in North Dublin.

Responsibilities:

• Responsibility for the timely, accurate and efficient management of documents including access and revision control.
• Manage and implement on the floor documentation control system.
• Creation and revision of Standard Operation Procedures (SOP’s), Work Instructions (WI’s) are required.
• Drive the Documentation life cycle system to ensure documents are approved in timely manner as per scheduling requirements.
• Work with SME’s and various internal and external stakeholders to ensure technical documentation updates are created and approved.
• Collaborate with QA, Supply chain and Operations core functions.
• Ensure Compliance with all regulatory GMP, Safety and Environmental Requirements.
• Report status of documents, identify areas of opportunities and action plans required.
• Coordination of Quality Notifications, CAPA’s and overall Deviation management.
• Manage ‘’Live’’ Documentation updates and report progress on documents
• Ensure effective planning, common understanding and targets for specific documentation
• Maintains a thorough knowledge of documentation needs.
• Provide updates on a regular basis to functional directors, associate directors managers on deviation, documentation and CAPA’s.
• Identify Risks, Gaps and Opportunities related to documentation – work with Area Owners and Subject Matter Experts to ensure documentation updates are approved.
• Collaborate with all the site functional areas and other support teams.

Qualifications & Experience:

• A minimum of level 6 qualification in a Science, Engineering, or Project Management discipline.
• Experience in the Pharmaceutical GMP regulated industry desirable.
• Excellent verbal and written communication skills.
• Ability to work independently and as part of a team in a cross functional collaborative environment.
• Experience working with GMP Documentation Management Systems.
• Should be proficient with Microsoft Office tools, (MS WORD/PowerPoint/ Microsoft).
• Experience with SAP/Trackwise/Veeva Quality docs advantageous.
• High level of attention to detail and strong planning ability.
• Experience with technical writing.