14028 – QA Specialist – Carlow Contractor

Purpose:

This is an 11 month contract position with a 4 shift cycle.

Responsibilities:

• Work a 4-cycle shift pattern role.
• 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 .
• 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.
• Be involved in customer complaint investigation if required.
• Support the annual product quality reviews if required.
• 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 company Six Sigma tools and support implementation of Model Area within operations from the start.

Minimum Qualifications and Experience: 

• Degree qualification or equivalent (Science, Engineering, Technical.)
• Experience in Sterile Manufacturing.
• Fully understand relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements.
• Have Operational experience of quality systems in a dynamic manufacturing environment e.g. SAP, Trackwise, MES.
• Have Technical knowledge of sterile manufacturing processes.
• Sterile filling processes and equipment and support services experience.
• Lean Six Sigma Methodology experience desired.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Demonstrable analytical and systematic problem-solving skills.