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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

QA Specialist (Investigation Lead)


Reference:RK5386 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing Coordinator

QA Specialist (Investigation Lead)
Hybrid
RK5386
Contract 12 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.




The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following





Key Responsibilities:

  • Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing comprehensive compliant documentation of all findings.
  • Clear and concise technical writing of complex investigations
  • Drive improvements to the investigation process
  • Present investigations to regulatory inspectors and internal auditors
  • Clearly communicate investigation progress to impacted areas and leadership
  • Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.
  • Project management of the investigations end to end
  • Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
  • Build effective relationships across functions.
  • Navigate through ambiguity and provide a structured problem-solving approach.
  • Able to apply inductive and deductive reasoning in the investigation process



Education and Experience:
  • Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
  • Detailed technical understanding of fill/finish operations
  • Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
  • Experience leading complex investigations
  • Experience participating in and leading cross-functional teams


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.