Technical Writer

CPL

Limerick

Technical Administrator / Technical Writer (12 Month Contract. To provide support for the technical/validation documentation and support activities within NPI Team to ensure that all activities associated with change control and general documentation support tasks are completed in a fully compliant manner in accordance with the requirements of company Validation/Quality Policies and Procedures. The role requires collaboration with Quality Engineering to ensure Validation/Quality Policies and Procedures are maintained. Responsibilities: Main areas of responsibility: Perform technical writing activities and assist the project engineers in the generation of validation documentations including URSs, FATs, SATs, test plans, deviations and discrepancies. Update and edit Operations Procedures, Work Instructions, project manuals, project presentations and reports. To provide assistance with Change Control process to ensure that change implementation activities and deliverables are coordinated effectively in order to meet both the TRB and CCB requirements and timelines. Help coordinate FMEA sessions with Validation and Engineering as needed. Assist with attachment and upload of deliverables associated with change control. Help with non-critical Validation execution under direction of Validation Engineer. Assist with purchasing and spare parts ordering. Ensure accuracy and consistency of the technical/validation documentation. Ensure all quality/validation documents are authorized and appropriate compliance approval is gained. Update procedures as required. Skillsets Required. Expertise in the use of Microsoft Word, Excel and Power Point and electronic document management systems. Excellent verbal and written communication skills. Excellent customer service, interpersonal and team collaboration skills are essential. Works independently and/or within team to accomplish job objectives. Self-Starter. Establishes and follows priorities. Suggest and sometimes may implement innovation and continuous improvement within the technical/validation writing process or within the Engineering process. Builds cross functional and cross-departmental support, fostering overall effectiveness. Education and Experience Required for Role. Essential: Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base. Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations. Desirable: Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry. Experience working in a regulated environment would be an advantage.

880 days ago