Quality Assurance Associate

Team Horizon currently has an exciting permanent opening for a QA Associate to work at our client’s facility in Sligo. This is an exciting opportunity to join a fast paced start up environment, where you will be responsible for supporting the operation of the Quality Management System (QMS) and carrying out quality related activities as directed by the Quality Assurance Supervisor (QAS), the Quality Manager (QM) and / or the Qualified Person (QP)
 
Why you should apply:

• This is an opportunity to work with an established Irish owned Early Phase supply partner, who value patient safety and Quality above all else.

 
What you will bedoing:

• The QAA supports the QAS and/ or the QM in the delivery of the following elements of the site QMS:


• Preparation, routing for approval and filing of Standard Operating Procedures (SOPs)


• Preparation, routing for approval and filing of Change Control Requests (CCRs), Deviations and CAPA


• Preparation and updating of training records and management of the Training Program


• scheduling, conducting and reporting on internal audits


• Preparation and submission of Manufacturing and Importation Authorisation (MIA) variations


• Participating in and ensuring follow up to risk assessments


• Conducting quality control / assurance activities at
  
  
  
  • goods receipt,
  
  
  • incoming inspection,
  
  
  • transfer to inventory and / or quarantine
  
  
  • production operations
  
  
  • product approval and release
  
  
  
  


• Ensure that the principles of Good Manufacturing Practice (GMP) are understood and followed.


• Ensure that correct gowning and personnel hygiene procedures are followed at all times. 


• Ensure that all documentation is completed correctly in a clear and legible manner as required in accordance with ALCOA+ principles. 


• Follow the requirements of Standard Operating Procedures (SOP’s)


• Follow and complete assigned training programs.


• Be familiar with and ensure that Health & Safety requirements are complied with.


• Preparation of User Requirement Specifications (URS)


• Compiling equipment and facility documentation including operational, technical as well as maintenance instructions and information.


• Conducting Risk Analyses (RA) on new equipment, facility or processes


• Preparation and assisting in the execution of Installation Qualification (IQ), Operational Qualification (OQ and Performance Qualification (PQ) protocols.


• Compilation of qualification / validation summary reports


• Assisting in resolution of any deviations that arise during qualification / validation activities


• Periodic (annual) review and issue of the Validation Master Plan (Schedule)


• Provision of general project management support for the site.


• Ensure that the management team is kept abreast of progress during qualification / validation activities and any deviations that may arise.

 
What you need to apply:

• Degree in Science/Engineering/Quality preferred


• A minimum of 1 + years’ experience in the day-to-day operations in a highly regulated GMP manufacturing environment.