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Quality Assurance Documentation Specialist

  1. East
Carlow
  1. Contract
Competitive
  1. Compliance / Quality Assurance
32030

This vacancy has now expired

Quality Assurance Documentation Specialist – Leinster – 6-month contract

With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Quality Assurance Documentation Specialist to join their team to support multiple capital projects taking place onsite in Leinster.

This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US. 

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Responsible for the control, operation, and maintenance of the site Central Documentation Control system.
  • Be a document system expert; this will include document, review, approval, and document system workflow oversight.  e.g., SOP's, work instructions, master forms etc. Support documentation generation, review, and approval in line with the standard approval process. 
  • Support site activities through maintenance/ monitoring of associated databases including MEDS, Quality Docs etc.
  • Establish and effectively manage information management systems, develop reports, presentation, projects, timelines, and correspondence utilising many different computerised systems when and if required . 
  • Use standard systems including MS Word, Excel, PowerPoint, Outlook and various company and industry specific software. 
  • Support department/site to be audit ready.
  • Facilitate site wide awareness of GMP activities; may be facilitated by means such as effective use of communication forums, development, and facilitation of training programmes.
  • Coordinate & manage special projects within the area/division.
  • Complete department specific assignments; including SOP administration; coordination of training, GMP Document Tracking; information repository coordination and compliance etc as required.
Requirements:
  • Experience and/or a particular skill set in their area of expertise that adds value to the
    Business; ideally in a manufacturing, preferably GMP setting.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required.
  • Understanding of Lean Six Sigma Methodology preferred
If you are interested initially, please apply now for immediate consideration and further information

The candidate must have the rights to work in the location stated in the job advert.

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