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Aerogen Ltd.

Document Control Administrator

Aerogen Ltd.

  • Galway
  • Negotiable
  • Permanent full-time
  • Updated 20/10/2017
  • Bernice Faherty
this job is expired
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Description

Co-ordination of workflow and prioritization including capture of relevant metrics. Additionally Quality systems support to Quality Engineering and assistance with appropriate continuous improvement activities

 

  1. Authority Assignment:

During periods of absence, the Quality and Regulatory Affairs Director shall ensure that all the responsibilities of this position are appropriately assigned.

           Duties/Responsibilities:

  • Responsible for the Q Pulse record management system (the computerized quality system tracking tool). This includes development and improvement projects, as appropriate.  
  • Responsible for the document control system including co-ordination of DCR process and ongoing compliance.
  • Will generate reports for data trending and analysis of the quality system (as required). 
  • Will handle all administrative activities to support Document Control and Quality Records Storage including trending reports and tracking activities to assure compliance and in line with identified timelines.
  • May assist or perform internal audits and assist in preparation for external audits, as required. 
  • Other quality system projects as necessary.

          Education/Experience:

  • Certificate/Diploma in Quality Assurance or equivalent industrial experience within the medical device industry, of which at least two years must be within a quality assurance or related role.

•     Excellent verbal and written communication skills.

•     Excellent attention to detail skills.

 

  1. Specific Requirements:
  • Ability to work within a team environment to achieve agreed company goals.
  • Ability to communicate effectively with all levels of the company.
  • Ability to meet deadlines.
  • Good understanding of ISO 13485 and FDA QSR quality standards.
  • Proficiency in use of desktop software applications such as MS Office 

 

  1. Environmental Conditions:

Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.

 

Ref: 100
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Aerogen Ltd.

Aerogen Ltd.

 

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