Website Ref: TPM03774
Our client is a global biopharmaceutical company in Carlow who is looking for a QA Specialist. The successful candidate will be responsible for performing reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk. This role is a 4 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.
- 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 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 support implementation of Model Area within operations from the start.
Qualifications & Experience:
- Degree qualification or equivalent (Science, Engineering, Technical).
- 4+ years of experience in sterile filling processes and equipment and support services experience.
- Lean Six Sigma Methodology experience desired.
- Experience in Sterile Manufacturing.
- Technical knowledge of sterile manufacturing processes.
To apply for this job email your details to email@example.com.