Quality , Science, Pharmaceutical & Food

Quality Assurance Technician

  • Contract
  • Swords, County Dublin, Ireland
  • 42002834

PE Global are currently recruiting for a Quality Assurance Technician for a client site in Dublin.

 

Initially 11 Month Contract

 

Provides Quality Assurance support to an assigned area. Non-supervisory, provides advice in areas of processes and procedures. Role holder ensures efficient processes and procedures are maintained within the boundaries of regulatory compliance for relevant GxP.

Key Responsibilities:

  • Participate/provide guidance during electronic Batch Record design meetings.
  • Review functional and configuration specifications.
  • Participate in development, review and approval of operational qualification testing strategy.
  • Assessment of change requests to electronic Batch Records released for use in production.
  • Review and approval of operational release testing packs.
  • Input, review/approval of change controls and track/close change tasks.
  • Participation in the generation and approve risk assessments.
  • Review and approval of new/updated Work Instructions, SOP’s and Competencies relating to electronic Batch Records.
  • Quality reviewer/approver of electronic Batch Record design related deviations.

Qualifications & Experience:

  • Related experience in biopharmaceutical / pharmaceuticals.
  • Must have thorough knowledge of biopharmaceutical manufacturing and associated global regulatory GMP/GDP requirements.
  • Must have demonstrated understanding of electronic Batch Record
  • Demonstrated ability to be a Quality Assurance Technician

 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***