17190-QA Specialist-Carlow Contractor

This is an 11-month contract.

Purpose

The Quality Assurance Specialist is required to

• Report to the Quality Assurance IPT Manager
• Work a 4 shift pattern role
• Have strong Technical knowledge of sterile manufacturing processes
• Perform timely reviews of batch documentation/investigations/reports highlighting and assisting 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
•  Have a full understanding of relevant quality and compliance regulations and 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

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 (EBRs) / 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
• 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