Quality Assurance Specialist - Quality Control

  • Dublin
  • Temporary 12 months
  • JO-1905-64476_1557829836

Summary

Responsibilities

  • Serve as Quality Assurance SME for quality control activities maintaining knowledge of industry standards and regulatory requirements to ensure all quality control activities are compliant.
  • Active member of the QA Operations team ensuring on-time disposition of finished product. This should be achieved through completion of the following activities:
    • Review and assess QC deviations; including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
    • Review and assess QC Laboratory Investigations
    • Review and approve QC generated Corrective and Preventive Actions (CAPA); including tracking, follow-up, and reporting/trending and evaluating CAPAs for effectiveness.
    • Provide Quality support to QC department in method transfer or validation activities.
    • Support the work of the Quality Systems and Compliance team by the coordination and optimization of Quality Management Records relating to Deviation, Change controls and CAPA.
  • Support Global Complaints Handling Unit (GCHU) in complaint investigations.
  • Supports the business through coordination of day to day operations and change management relating to Quality e-Systems such as TrackWise
  • Generation, development and communication of Site Quality Metrics and measurements to support the on-going development of site compliance.
  • May create or revise standard operating procedures relating to various quality system elements
  • Represents Quality Assurance to guide various projects and technical meetings, as needed
  • Responsible for documenting and reporting compliance issues to management.

Requirements:

  • Minimum of B.S. degree in Chemistry, Biology or related field
  • Minimum 3 years of experience in QA and/or QC
  • Thorough knowledge of cGMP/GLP/GDP and international regulatory requirements.
  • Demonstrated ability to coordinate and drive improvement in processes supporting Quality Systems or Quality Control.
  • Proven ability to identify, influence and drive process improvement.
  • English fluency written and spoken (the Company language).
  • Efficient in SAP, firstdoc. and Trackwise® would be an advantage.

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