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Quality Systems Officer, Waterford



Waterford, Ireland 

Job Category:

Biotech/Pharma, Science

EU work permit required:


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Job Description:

The Opportunity

Team Horizon is seeking a Quality Systems Officer to join a leading Pharma company in the South East. The primary role of a quality systems officer is to ensure that all quality systems are maintained in compliance with company, regulatory and health & safety requirements.

Additionally, this is a key role for the site with regards to the design and mapping of our current quality system processes to meet current and future organization requirements

The Role

  • Assist with the design and mapping of current quality system processes to meet current and future organization requirements
  • Responsible for ensuring that all quality systems are in compliance with data integrity requirements
  • Support administrative resources across the organization to ensure consistency and linking of processes and documents
  • Oversee the collection, collation and reporting of site quality metrics
  • Provide support in the development of procedures and instructional documentation
  • Provide operational and project support, where required
  • Administrative support for electronic management systems
  • Investigator and evaluator for any Quality System incident reports
  • Change Owner and Evaluator for Quality System change controls
  • Continuously identify and implement system improvements
  • Generation and presentation of company metrics
  • Ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLP, SOP’s, regulatory regulations and guidelines, safety and environmental guidelines
  • Implement Safety requirements as per site documentation including SOPs, Safety Statement and COPs
  • Continuously promote a positive safety culture by leading by example
  • Reports any Defects

The Person

  • A third level education or equivalent work experience in a regulated environment
  • Technical ability to develop procedures and review processes
  • cGMP guideline knowledge
  • Knowledge of QUMAS EDMS and change management system
  • Well-developed, proven experience with Microsoft Office suite
  • Good organizational and interpersonal skills will be required
  • Excellent communication and presentation skills
  • Ability to define and manage own tasks and schedules essential

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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