QA Specialist

Summary:

A biopharmaceutical company in Carlow is seeking a QA Specialist. The role involves reviewing batch documentation, investigations, and reports, identifying concerns, and aiding in their resolution in line with associated risks. This position operates on a shift basis to support operations 24/7.

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.
• 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 the 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 Client’s 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).
• Experience in Sterile Manufacturing.
• Sterile filling processes and equipment and support services experience.
• Technical knowledge of sterile manufacturing processes.
• 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.