Aerie Pharmaceuticals has a job for you

 

Job Details


Quality


Quality Assurance Specialist  Athlone, Co. Westmeath,   : 3/9/2018
Job Description

Job ID#:

166

Job Category:

Quality

Position Type:

Employee


Details:

 
The QA Specialist is a key part of the Quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of the current Good Manufacturing Practice (cGMP) regulations. This role will ensure that the manufacturing team has direct and effective support to ensure manufacturing of Aerie products meets Right First Time espectations while maintaining a high standard of continuing compliance and process improvement.
 
Essential Duties, Functions and Responsibilities:
·         Works with manufacturing, technical and other quality colleagues as part of a team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
·         Manages all manufacturing deviations, CAPA‘s and associated processes and provide Monthly KPI’s on such.
·         Assist in the completion of Customer Quality Complaint investigations as they relate to manufacturing
·         Perform detailed batch record review of finished products prior to / for QP release.
·         Quality Assurance oversight of in-process quality inspection within manufacturing/packaging.
·         Assist in the execution of the internal audit program including the performance of audits as required.
·         .
·         Review of batch record paperwork on the manufacturing shop floor and to manage of the control of SOPs and associated documents.
·         Participates as required in training program development and implementation. 
·         Notifies manager of compliance questions and issues
 

Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

 
Job Requirements

 
Details:

Skills/Knowledge Required:
  • Experience in managing a Deviation, CAPA and Non-conformances in Sterile Manufacturing facilities, ensuring all issues are investigated and approved by key management and stakeholders.
  • Experience in a sterile product GMP manufacturing environment and familiarity with the associated technologies and quality processes.
  • Demonstrated experience in Risk Analysis, Investigation, Problem Solving, and associated Techniques as a Quality SME
  • Experience in batch record review and process improvement.
  • Experience in the performance of audits.
  • Proficiency with Microsoft Word, Excel, PowerPoint, Visio and ideally an electronic document system.
  • Ability to interpret technical procedures, SOP’s, GMP’s and applicable regulations and provide advice and guidance as required.
  • Strong attention to detail and precision in preparing, reviewing and issuing GxP documentation.
  • Very strong written and verbal communication skills.
 
Skills/Knowledge Desirable:
  • Experience working with: CAPA/ Deviation and Document Management Systems preferably Veeva Doc Control / QMS Systems or alternatively Q-Pulse or Trackwise type systems.
  • Experience in participation in GMP Regulatory body audits e.g. FDA, HPRA or equivalent.
 
Education Required:
  • Degree in a Science related discipline.
 
Experience Required:
  • 5+ years’ experience working in QA in a Sterile Product GMP Environment
  • 3+ years’ experience working as a Quality lead in a manufacturing facility or team.
 




 

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