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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Scientific Technical Specialist


Reference:RK22226 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Technical Specialist

Scientific Technical Specialist
RK22226
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.



Duties:

  • Individual will hold the position of risk lead of the contamination control and downstream QRA (quality risk assessments- involves owning all pre work, holding and leading reviews sessions with interdisciplinary teams, and owning the update and approval of the QRA on the electronic GMP system)
  • Responsible for Downstream Quality Risk Assessments (QRA's), including contamination control QRA's Responsibility for the timely, accurate and efficient management of documents including access and revision control.
  • Hold the position of QRA contributor to other risks assessments on site.
  • Manage “Live” Documentation updates from the operations floor.
  • Turnaround and issue documentation as per Operations Schedule
  • Manage and implement on the floor documentation control system.
  • Drive the Documentation Life Cycle System to ensure documents are approved in as per Scheduling requirements.
  • Work with various Subject Matter Experts to ensure technical documentation updates are approved.
  • Creation and revision of Standard operating Procedures (SOPs) Work Instructions (WI’s) as required
  • Work closely with QA, Supply chain and Operations core functions
  • Ensure compliance with all regulatory GMP, Safety and Environmental requirements.


Education and Experience :

  • At minimum, Degree in a relevant Qualification and Biopharmaceutical experience
  • Experience working with GMP Documentation Management Systems
  • 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,



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