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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

QA Compliance Specialist


Reference:RK22831 Location: Carlow
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Compliance Specialist

QA Compliance Specialist
RK22831
Contract – 11 months
Carlow
Hybrid


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. 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.


This role will be responsible for supporting the Engineering Department in a GMP and Sterile Environment. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.


Duties:

  • Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure
  • analysis, root cause determination and implementing corrective actions.
  • Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies.
  • Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, JSA’s, PM's and change controls.
  • Accountable for leading investigation analysis, identifying true root cause, identifying gaps and actions to close gaps. Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS,
  • Technical Engineering in completion of tasks.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned
  • Support Audit Readiness activities


Experience and Education:

  • Third Level Degree qualified in a Science/Engineering or related discipline.
  • 3-5 years prior related work experience ideally in a manufacturing, preferably GMP setting.
  • GMP Audit experience in the pharmaceutical industry
  • Experience with documentation such as SOP’s, SWI’s, training documents, JSA’s, PM's and change controls


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