We are looking for someone with a science background, or relevant training, and a keen interest in documentation, writing, and information design for a role with a leading biopharmaceutical company based in Cork. The successful candidate will become an integral part of a project team and will thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. A high level of initiative, energy, and motivation are key role requirements, as well as excellent organisational skills. Appropriate technical writing training will provide the successful applicant with the skills to draft, write, and update technical documentation such as SOPs, BMRs, protocols, and other technical reports as necessary.
TWi is an exciting, high-growth company based in Cork that delivers outsourced business-to-business technical writing, editing, and documentation solutions. We work primarily with clients who are involved in the pharmaceutical, biopharmaceutical, medical technology, hi-tech, and software industries to create deliverables such as training material, standard operating procedures (SOPs), batch manufacturing records (BMRs), protocols, and other technical reports.
Cork based client site.
Full-time, permanent subject to a probation period of six months.
Tasks and responsibilities
– Implement documentation updates and coordinate review cycles in the content management system.
- Draft and edit batch records, SOPs, and logbooks, as per redlines provided by SMEs and feedback received at each stage of review.
- Create Visio diagrams.
- Coordinate document reviews to ensure that each stage of review meets the date outlined in the planned timeline.
– Assist with project administration and reporting.
- Plan and manage timelines for documentation updates based on their planned effective dates.
- Liaise with other project members to ensure clear cross-project communication, maintain visibility on project progress, and make necessary escalations to the Project Lead.
- Assist the Project Lead with status reporting, by creating and maintaining trackers to capture various aspects of project progression.
- Assist the Project Lead with general admin activities, such as printing project-related material and creating posters.
– Manage documentation updates in the change control system.
- Initiate and manage change requests in the change control system.
- Compile change summaries and associated justifications for all documents included in the change request.
- Raise associated compliance actions to be completed in accordance with the change request.
- Liaise with the necessary parties to ensure compliance actions are completed within the planned timeline.
– Participate in departmental activities and assist other team members.
- Chair compliance-related meetings.
- Assist with housekeeping duties on the production floor.
- Assist with document issuance on the production floor.
- Respond to ad hoc task requests.
- Assist with document updates.
- Relevant qualification in engineering, science, technical writing, English, or specific industry / job-related training.
- Ability to identify and resolve problems using own initiative.
- Excellent communication and interpersonal skills.
- Excellent written and spoken English.
- Proficient in the use of MS Word, Excel, and Visio.
- Strong ability to work to tight deadlines.
- Flexible working approach with a can-do attitude to adapt to changing business needs.
- Willing to learn new tools as required.
- Committed to understanding and applying quality processes.
- Ability to manage and report on assigned tasks in accordance with agreed priorities.
- Comfortable working independently and as part of a team.
- cGMP experience.
- Previous technical writing, documentation, or quality management experience.
Friday 27th September 2019