Quality Assurance Executive

  • Reference: GY46129
  • Job Type: Permanent
  • Location: Galway, Galway City
  • Category: Engineering, Technical & Manufacturing

My client a global generic and specialty pharmaceuticals company located in Co. Galway is looking for Quality Assurance Executive III.

Resposibilities:

  • 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.

 Qualifications:

  • 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.

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For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or email edyta.fleming@collinsmcnicholas.ie.


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Edyta Fleming

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  • Edyta Fleming
  • Recruitment Consultant
  • 091 706721
  • Connect with Edyta

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