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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Quality Assurance Technical Support Specialist


Reference:RK5277 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Senior Quality Assurance Technical Support Specialist
Hybrid initially - potential for remote
RK5277
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 Quality Assurance Technical Support Specialist is a senior position within the QA function which will typically report to a QA Manager or Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.



Key Responsibilities:

  • Accountable for Quality oversight of processes and procedures related to Packaging, inspection Process Development, Validation, Engineering, Facilities/Utilities.
  • Quality review and approval of Validation and qualification documentation and SOPs to support site validation activities:
- Review of DS & QRAES documents

- Review of validation Plans, Protocols, IOQ, PQ and associated validation documents

- Review of executed validation documents and reports

  • Perform all activities in compliance with safety standards and SOPs
  • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
  • Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.


Education and Experience:
  • University degree in a Science-related discipline
  • 7 years’ relevant experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of automation / IS projects
  • Ability to work independently and remotely with minimum direct supervision


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