Website Ref: TPM04168
An Operations Documentation Specialist is required for a biopharmaceutical company in North Dublin.
- 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.
To apply for this job email your details to patricia.arrue-elorza@Tandempm.ie.