Technical Writer- 12-month Contract

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).

Job Description:

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.

Role:

Essential Skills:

• 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.
• 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

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

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