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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

QC Instrumentation Maintenance Specialist


Reference:RK21700 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst

QC Instrumentation Maintenance Specialist
RK21700
Contract – 11 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 role of Quality Control (QC) Instrumentation Systems Specialist operates as part of a dynamic team to plan, execute, and managing the activities required to maintain the testing infrastructure of the QC lab. The team working s is one of collaboration, coaching, and teamwork to provide Quality oversight and expertise to the QC team to support a High Performing Organisation.



Duties:

  • The QC Instrumentation Specialist roles and responsibilities include but are not limited to the following:
  • Responsible the qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards
  • Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation.
  • Support the QC department for troubleshooting, investigations, and deviations as an SME.
  • Manage deviations, CAPA’s and change control’s related to the QC and team priorities.
  • Assist with implementation of Quality Chapters to ensure we maintain best practices and build excellence into our QC systems and processes.
  • Author and revise local SOPs, work instructions, and guidelines.
  • Serve as an SME for regulatory and internal inspections and audits.
  • Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop.


Experience and Education:
  • A bachelor’s degree in Engineering, biological science, or related field.
  • 3 years’ experience in CSV and/or CQV for laboratory systems and instrumentation
  • Experience in regulatory audits.
  • Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).



If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.