Quality , Science, Pharmaceutical & Food

QA Specialist – Shift

  • Contract
  • Remote
  • Carlow
  • 41935814

PE Global are recruiting for a QA SPECIALIST on behalf of our Bio client site in Carlow:

 

The Quality Assurance Specialist is required to

  • Work a 4 shift pattern role
  • Technical knowledge of sterile manufacturing processes
  • Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
  • Respond quickly to unplanned events, technical issues
  • Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
  • Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
  • Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
  • Support the spot check/walk-through process of the production lines
  • Involved in customer complaint investigation if required
  • Support the annual product quality reviews if required

 

POSITION RESPONSIBILITIES

  • Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
  • Understanding of sterile manufacturing operations is preferred.
  • Ability to learn and utilize computerized systems for daily performance of tasks.
  • Ability to prioritize, manage multiple tasks, and meet deadlines.
  • Perform timely reviews on batch documentation ( EBR’s ) / line clearances/ assist in the resolution of concerns commensurate with the risk.Liaise with other Department representatives to promote improvements in GMP and Quality standards
  • Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
  • Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.
  • Foster a culture of continuous improvement by deploying MSD Six Sigma tools and support implementation of Model Area within operations from the start.

 

EDUCATION AND EXPERIENCE

Technical

  • Sterile filling processes and equipment and support services experience
  • Lean Six Sigma Methodology experience desired

 

Education

  • Degree qualification or equivalent (Science, Engineering, Technical)
  • Experience in Sterile Manufacturing

 

General

  • Good organizational skills and attention to detail
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
  • Ability to learn and utilize computerized systems for daily performance of tasks.
  • Strong influencing skills
  • Demonstrable analytical and systematic problem-solving skills

 

 

Please click the link below to apply, call Audrey on 021- 4297900 or alternatively send an up to date CV  Audrey.mccarthy@peglobal.net

 

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

 

 

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