Fantastic opportunity for a QA Specialist is a world-class Biologics manufacturing facility.
This is a 4 cycle shift role (33% allowance) sterile manufacturing processes
Duties and Responsibilities:
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
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.
Degree in a related area
Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
Understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
strong experience in pharmaceutical manufacturing (ideally sterile manufacturing)
For a confidential discussion and more information on the role, please contact Rory Walsh.