Contact: Niamh Hlubek
Telephone: 086 8168298
Technical Writer - Contract
Our client, a medical device company in Limerick are currently looking to recruit a Technical Writer for their site on a contract basis
To provide support for the technical/validation documentation and support activities within engineering to ensure that all activities associated with change control and general Engineering support tasks are completed in a fully compliant manner in accordance with the requirements of Validation/Quality Policies and Procedures. The role requires collaboration with Quality Engineering to ensure Validation/Quality Policies and Procedures are maintained.
Perform technical writing activities and assist the project engineers in the generation of all validation documentations including URS’s, FAT’s, SAT’s, test plans, deviations and discrepancies.
Update and edit Operations Procedures and 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 Engineering as needed.
Assist with attachment and upload of deliverables associated with change control.
Help with non-critical Validation execution under direction of Engineering.
Assist with purchasing and spare parts ordering
Support Engineering with planning and department development.
Provide training on quality systems.
Manages and monitors the change control metrics.
Ensure accuracy and consistency of the technical/validation documentation.
Ensure all quality/validation documents are authorized and appropriate compliance approval is gained.
- 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
- Establishes and manages engagement objectives and expectations, 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
Education and Experience Required for Role
- Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
- Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
- Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
- Experience working in a regulated environment would be an advantage
For further information on this Technical Writer role in Limerick please contact Niamh Hlubek 086 8168298 / firstname.lastname@example.org
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