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Details

QA Sr Associate


Reference:JSC00029968 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Nurse Associate, QA Specialist

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 Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Manager and is a core member of the site Quality Assurance team.


Duties


  • Perform complaint investigation related to product manufactured including Formulation, Filling, Inspection and Packaging.
  • Perform all activities in compliance with Amgen safety standards and SOPs
  • Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
  • Provide Quality support for triage and investigation of Deviations
  • Review and approval of Deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
  • Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
  • Review and approve cGMP records (e.g., deviations, CAPA, protocols, reports & SOP) ensuring compliance with appropriate documentation
  • Support continuous improvement and Operational Excellence initiatives
  • Any other tasks/projects assigned as per manager’s request.






Education & Experience

  • Experience with industry Investigating and complaints, Batch review.
  • Excellent written and verbal communication.
  • Experience working cross functional
  • Background, ideally within pharma either manufacturing, Quality, QC
  • Previous experience with batch review/investigations (min of 2 years’ experience) or willing to consider graduate at Masters or PhD level
  • Ideally some complaints handling
  • Experience working with dynamic cross-functional teams and proven abilities in decision making
  • Strong organizational skills, including ability to follow assignments through to completion
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigation
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
  • Operational Excellence experience
  • University degree. Engineering or Science related discipline preferred.

  • Relevant experience (2 yrs +) working in the pharmaceutical or biotechnology industry.