Technical Writer- 12-month Contract

Technical Writer- 12-month Contract
QPTech_IT_15102021

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

 

Clicking the “Apply Now” button means that you agree to the processing of your personal data for the purposes of current and future recruitment processes, carried out by QPTech in accordance with the provisions of the General Data Protection Regulation (GDPR) (EU) 2016/679. You also agree to share your personal data with other entities of QPTech and potential employers for purposes related to the recruitment process. QPTech may also contact you from time to time to inform you of events we are hosting that you may find interesting.

Providing data is voluntary, you have the right to inspect, correct or request deletion of your data at any time. A request to delete data means withdrawal from any further engagement in QPTech’s recruitment processes and will result in the immediate deletion of your data. If you do not agree, please do not click the “Apply Now” button.

Please visit QPTech’s website to read the full Privacy Policy.

Salary: 40,000-50,000/annum
Recruitment Contact

Contact: Vandana Sharma

Telephone: 0858704692

Email: hr@qptech.ie

Apply For This Job

Warning: CF7 DTX: Access denied to key: "ref" in dynamic contact form shortcode: [CF7_get_custom_field]. Please add this key to the Meta Key Allow List at https://www.qptech.ie/wp-admin/admin.php?page=cf7dtx_settings in /home/customer/www/qptech.ie/public_html/wp-content/plugins/contact-form-7-dynamic-text-extension/includes/utilities.php on line 923

    Upload CV:

    Share This Job
    Be social and spread the word ...