13612- QA Specialist (QAV) – Carlow Contractor

Responsibilities:

The Quality Assurance Specialist within the Company  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.
• 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
• 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