Overview
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
JOB DESCRIPTION & SPECIFIC OBJECTIVES
The Quality Assurance Specialist within Our Company is required to:
* 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 audrey.mccarthy@peglobal.net
***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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