Overview
The Quality Assurance Specialist within Our Company is required to
* 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
Responsibilities
* 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.
Reporting Structure
Reports to Quality Manager
Qualifications & Experience - Knowledge & Skills Requirements
Skills and Knowledge
* 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
Shift Pattern
* This is a shift position – 4 cycle 12 hours per shift
* Week 1- long week: Monday – Tuesday Days, Friday, Sat, Sun nights
* Week 2- short week: Wed and Thurs Days
* Week 3: Long week: Monday – Tuesday nights, Friday, Sat and Sun Days
* Week 4: short week: Wed and Thu Nights
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