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Quality Assurance Executive Level III

Job description

Description:

  • Manage the company’s Permanent and Temporary Change Management system
  • Maintenance of the incident report system (unplanned deviations), supplier non-conformance system and the CAPA system
  • Manage the internal audit program
  • Manage Customer Quality Complaints/Medical Device Vigilance systems
  • Manage the company’s GMP training program
  • Manage the company’s routine commercial stability program
  • Prepare monthly/quarterly/annual KPI/Management review data and annual product quality review reports
  • Perform detailed batch record review of finished products prior to QP/QA release
  • Deputise for the QA Team Leader if required

 

Minimum qualifications and essential functions for this position:  

  • Minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 5-8 years relevant experience within a pharmaceutical company with a minimum of 2 years’ experience within a Quality Assurance role.
  • Experience of sterile manufacturing desirable but not essential.
  • Experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, and batch release.
  • Experience of TrackWise or similar electronic document management systems is highly desirable.
  • Excellent communication (oral & written) and presentation skills.
  • Ability to handle multiple tasks in a fast-paced environment with strong organisational and time management skills.
  • Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (Word, Excel, PowerPoint etc.)
  • Proficiency in speaking, comprehending, reading and writing English is required

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

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