QA Specialist - Senior

  • Panorama Dublin
  • Berkley Group

I f you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Aleksas Kremenskason +353 (0)87 2727949 or send your CV to

Bio-pharmaceutical company based in Dublin is hiring for a Senior QA Specialist. The successful candidate will be responsible for the Quality oversight processes and procedures related to Packaging Technology Transfer/NPI, Validation and Engineering.
Key Responsibilities:

  • Quality review and approval of Transfer, Validation and qualification documentation and SOPs to support site validation activities .
  • Quality Review and approval of MBRs and BOMs.
  • Perform all activities in compliance with Amgen safety standards and SOPs
  • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
  • Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA record.

Preferred Qualifications:

  • University degree. Science or engineering related discipline preferred.
  • Relevant experience (5 years +) working in the pharmaceutical or biotechnology industry providing quality direction for NPI/ technology transfer / packaging projects.
  • Knowledge of devices/combination products regulations.
  • Ability to work independently and remotely with minimum direct supervision.
    Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to
  • #J-18808-Ljbffr