Collins McNicholas

The Role – 

  • Ensure highest Quality, Compliance and Safety standards are adhered to.
  • Protocol/report authoring/execution/oversight/approval as appropriate
  • Recommend technical approaches in line with global and local standards.
  • Ensure supply of high-quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.
  • Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
  • Participate in problem solving teams across all areas of the Vaccine IPT
  • Support process related deviations and reports.

Your day to day – 

  • 5 years’ experience in a regulated manufacturing environment.
  • Demonstrated knowledge in validation and other pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality, analytical)
  • Demonstrated delivery of a significant process / technical project

Technical

  • Demonstrated process qualification and validation SME background within the pharmaceutical or Biopharmaceutical industry.
  • Demonstrated capability to deliver results RFT, in a FDA / HPRA Regulated production environment.
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated high level of problem-solving and facilitation skills.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.

People

  • Demonstrated successes in a team environment, such as project teams, Six Sigma team etc.
  • Leadership ability including change management skills with a continuous improvement focus
  • Experienced at holding team members responsible for results.

Education

  • Hon. Degree or Masters in a Science or Engineering discipline
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional is desirable.
  • Evidence of Continuous Professional Development.

For a confidential discussion and more information on the role, please contact Edel on 021 4911065 or email edel.obrien@collinsmcnicholas.ie

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