QA Specialist– Carlow

JOB DESCRIPTION&SPECIFIC OBJECTIVES PE Global is currently recruiting QA Specialist on behalf of our client based in Carlow:

11-month initial contract- with 33% Shift Premium– 4 cycle shift pattern, 12 hours day/nights

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

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

Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

QUALIFICATIONS&EXPERIENCE– KNOWLEDGE AND SKILLS REQUIREMENTS Typical Minimum Education

Bachelor’s Degree or higher preferred in a Science discipline

Typical Minimum Experience

1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing

Experience in SAP, MES, Trackwise desirable

Technical

Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices

Knowledge of cGMP and GDP essential Report, standards, policy writing skills required

Competent in the use of MES and SAP

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV

**Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland**

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