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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior QA Associate (Shift)


Reference:RK4145 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Senior QA Associate (Shift)
RK4145
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.


Key Responsibilities:

• Perform all activities in compliance with safety standards and SOPs.
• Write, review and approve Standard Operating Procedures in accordance with Policies.
• Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
• Review and approval of deviations for closure ensuring compliance with appropriate documentation.
• Participates in customer complaint investigations.
• Provides training and advice to staff in order for them to perform their desired functions.
• Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
• Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
• Review and approve cGMP records ensuring compliance with appropriate documentation.
• Support continuous improvement and Operational Excellence initiatives.
• Any other tasks/projects assigned as per manager’s request.


Experience and Education:

• University degree. Engineering or Science related discipline preferred.
• Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
• Experience working in aseptic operations, protein formulation, vial and syringe filling.


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