Quality Assurance Specialist 11-Months Contract

We are looking for a QA Specialist, for an 11 months contract with a Pharmaceutical company fully based in Carlow.

The QA Specialist will be responsible to work for a 4-shift pattern role, we are looking for a candidate with extensive knowledge of relevant quality and compliance regulations, and knowledge of requirements for cGMP, US, and EU regulatory requirements. Some of the daily tasks will include, conducting, reporting, and display of Quality right first time,audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance,  Supporting the spot check/walk-through process of the production lines, 

Key Responsibilities:

• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.
• Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
• 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. 
• Understanding of sterile manufacturing operations is preferred.

What experience makes me an eligible candidate for the role?:

• Sterile filling processes and equipment and support services experience
• Lean Six Sigma Methodology experience desired
• Degree qualification or equivalent (Science, Engineering, Technical)
• Experience in Sterile Manufacturing

Does this sound interesting to you?

Then hurry up and register your CV or get in touch with me at abril.keinrath@recruiters.ie

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