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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Manufacturing Specialist - Investigation Lead


Reference:RK3800 Location: Dublin South
Qualification:Not ApplicableExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Specialist

RK3800
Manufacturing Specialist (Investigation lead)
12 month contract
Biopharmacuetical manufacturing
Hybrid


Description:

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:


  • 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 processEducatin


Education and Experience
  • Bachelor's Degree in Science or Engineering
  • 5+ years of directly related experience in a biotech/pharma manufacturing industry
  • Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, leading complex investigations and quality systems.
  • Detailed technical understanding of fill/finish operations


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