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Quality Executive Level II

Job description

Responsibilities:

  • Support Third party manufacturers on batch review documentation, deviations and incident reports.
  • Prepare and assess change control documentation, while review the annual product quality reports.
  • Involved in the QMS development and continuous improvement, supporting senior executives on batch reviews and any deviations.
  • Providing Quality Oversight of all products being released into US Market. The products are manufactured by third party Injectable manufacturing sites based in Bangalore.
  • This role supports affiliate injectable sites, an experience in third party manufacturing oversight and/or sterile manufacture is ideally required to help with analytical investigations.
  • Be involved in compliance and complaint investigations for the QA operations, meeting face to face with third party manufacturers and discussing batche reviews and deviations.

Requirements: 

  • Minimum of 5+ Years experience in the quality management and compliance area in Pharmaceutical or Medical Device
  • Understanding the role of Quality in the Pharmaceutical business
  • Strong Planner
  • Good time-keeping
  • Working closely with senior leadership

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

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent