CQV QA Specialist

2021-10-15 14:33:362049-02-28Team Horizon
Job TypeContractor
AreaDublinDublinIreland
SectorEngineeringQualityOperations & Manufacturing
Start Date
AdvertiserAshling Guthrie
Job Ref#2212
Job Views273
Description
Are you an experienced Quality Specialist with exposure to CQV? Would you like to work at a premier, state-of-the-art facility that enables and advance your best work?
If the answer is yes, read on to find out more about this exciting opportunity where you will have responsibility for Quality oversight on the design and qualification activities as part of the design, construction, qualification and start-up of a newBiologics Drug Substance manufacturing facility for Clinical Supply, Registration & Commercial Launch. 
 
Why you should apply:
  • You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.
  • You enjoy working in a culture of learning and collaboration and making a positive impact.
  • Leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions
 
What you will be doing:
  • Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
  • Quality SME for the execution and reporting phases of the qualification and validation activities associated with the facility.
  • Review and approve all documentation where required specific to Qualification / Validation activities.
  • Ensure any investigations / deviations associated with the validation activities are thoroughly investigated and closed in a timely manner
  • Oversee the Project Change Management Process and approve Project Change Requests where required.
 
What you need to apply:
  • Significant experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
  • Strong experience with Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
  • Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500
  • Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
  • Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
  • Track record of utilizing Risk Based Approaches to Qualification / Validation activities.
  • Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.
 
 
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