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 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***