Quality Validation Engineer

2022-08-04 10:21:532049-12-30Team Horizon
Job TypeContractor
LocationSligo
AreaSligoSligoIrelandSligo
SectorQuality
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2572
Job Views172
Description
Quality Validation Engineer – Team Horizon
 
We are currently recruiting an ambitious and experienced Quality Validation Engineer for our client who are a global biopharmaceutical leader, for their Sligo site.

Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
  • The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.
  •  
  • Excellent career progression opportunities.


What you will bedoing:
  • Develop and execute the qualification for Information Systems and GxP software systems.
  • Develop of life cycle documents necessary to address the validation lifecycle for Information Systems and GxP software systems (Planning, Risk, Implementation, and maintenance of the validated state).
  • Review of RCE/URS for new computer/automation/enterprise systems to ensure new systems meet AbbVie and regulatory requirements for computerised systems and data integrity ·
  • Coordinate with other global divisions, departments and/or outside contractors/vendors to implement/support the successful application of new technologies/ systems and ensure that the system design meets technical, customer, and regulatory requirements.
  • Lead the definition, design, and execution of computer/automation/ enterprise systems validation and verification activities throughout all phases of the SLC Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
  • Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
  • Ensure Quality System documentation is thorough, complete, and compliant including documents for new products.
  • Ensure compliance to training requirements is maintained.
  •  
  • Represent Quality at new product project meetings.

What you need to apply:
  • Bachelor’s degree in relevant science or engineering, plus one years’ relevant experience.
  • 3 years plus experience working in a highly regulated combination product/medical device / pharma manufacturing environment.
  • Experience of validating/testing computer systems together with good knowledge of compliance good practise (i.e., GAMP5, 21 CFR Part 11, EU Annex 11 and GxPs).
  • Experience of production and laboratory systems beneficial. Knowledge around MES, SAP, Plant Data Historian, Metrology Instruments and associated software.
  • Experience of IT infrastructure qualification as per regulatory requirements beneficial.
  • Experience with computer controlled equipment automation systems and Human Machine interphases beneficial. 
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Darcy Ainscough-Denton
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