Technical Lab Service Lead

  • Dublin
  • Permanent
  • JO-1902-64237_1549625038

Summary

Role
The QC COE lead is a specialised critically important role within the QC organisation to ensure efficient and effective compliant design, construction, qualification, and operation of a new facility. This tremendous opportunity will be responsible for all instrumentation across all labs, software systems; validation of instrumentation; instrumentation life cycle; instrumentation maintenance and calibration program; the stability program other supporting activities that go across all QC labs.

Responsibilities

  • The motivation to be an inspiring member of a high performing team.
  • The desire to continuously learn, improve and develop.
  • A great communicator, decisive decision maker and proven ability to deliver excellence.
  • Strong knowledge and experience of validation methodology.
  • Understand the maintenance and calibration program for all of the QC labs.
  • Ensure all QC instrumentation meets the currently requirements and monographs.
  • Has a good working knowledge on IT system and their interactions with lab instrumentation.
  • Ensures data integrity requirements is verified and maintained for the life of the instruments.
  • Strong knowledge on a stability program.
  • Delivery of area performance to meet or exceed performance or quality goals
  • Ensure compliance with cGMP and other business compliance regulations.
  • Promote and participate the implementation and maintenance of the relevant safety programmes.
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  • Participate and Comply with the MSD Quality Management System requirements.
  • Build relationship with IT, site engineering and vendors.
  • Good understanding on how to build good relationships with key partners, (external vendors etc.


Requirements

  • Degree qualification (Science/Quality/Technical).
  • Desirable evidence of Continuous Professional Development.
  • Preference Lean Six Sigma
  • 5-7 years industry experience with significant knowledge and experience in laboratory instruments, validation and life cycle.
  • Validation knowledge
  • Problem solving skills.
  • Leadership skills.
  • Ability to respond to changing priorities.
  • Communication skills.

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