Documentation Specialist

Orion Group Life Sciences are currently recruiting a Documentation Specialist on behalf of our Multinational Biopharmaceutical Client based in Swords, Dublin on an initial 11-Month contract.

Key Responsibilities:

This position will include a combination of the responsibilities as follows:

• 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 documentation updates are approved.
• Collaborate with all the site functional areas and other support.

Key Experience:

Key Personal Skills

• Networking skills within peer and other work groups across the site.
• Enthusiastic contributor to the creation and development of our site
• Exceptional communication skills and ability to communicate to multiple levels within
• Experience with technical writing.

General

• 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
• High level of attention to detail.
• Demonstrated ability to manage multiple priorities against ambitious timelines. Strong planning
• Strong problem-solving skills and ability to work cross-functionally.

Technical Experience

• Should be proficient with Microsoft Office tools, (MS WORD/PowerPoint/ /Microsoft)
• Experience with SAP/Trackwise/Veeva Quality docs advantageous.

Education:

• A minimum of level 6 qualification in a Science, Engineering, or Project Management discipline.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.