Recruiters Comments: Our client, A Medical Device industry, based at Limerick location is currently recruiting for an experienced Technical writer for initially a 12-month daily rate contract role, with highest possibility of multiple extensions. This role is likely to be Hybrid (2 days a week, if required).
You’ll be responsible for providing 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 our client Validation/Quality Policies and Procedures. The role requires collaboration with Quality Engineering to ensure our client Validation/Quality Policies and Procedures are maintained.
Main areas of responsibility:
- Perform technical writing activities and assist the project engineers in the generation of validation documentations including URS’s, FAT’s, SAT’s, 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.
- 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.
- 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.
- 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
- 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
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Contact: Vandana Sharma