18683-QA Specialist-QA-IPT-Carlow Contractor

This is an 11-month contract.

Purpose:

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, and technical issues.
• Operational experience of quality systems in a dynamic manufacturing environment  eg SAP, Track wise, MES
• Full understanding of relevant quality and compliance regulations and knowledge of requirements for cGMP, US, and EU regulatory requirements
• Conduct, report, and display Quality the 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.

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 Six Sigma tools and supporting the implementation of Model Area within operations from the start.

Requirements:

• Degree qualification or equivalent (Science, Engineering, Technical)
• Experience in Sterile Manufacturing
• Sterile filling processes and equipment and support services experience
• Lean Six Sigma Methodology experience desired.