Overview
Quality Assurance Specialist Jobs in Carlow, County Carlow, Ireland at Recruitment by Aphex
Title: Quality Assurance Specialist
Company: Recruitment by Aphex
Location: Carlow, County Carlow, Ireland
Purpose
The Quality Assurance Specialist 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
- Work well cross functionally and be an active team member
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.
Requirements
- Bachelor's Degree or higher preferred in a Science discipline
- 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
- Experience in SAP, MES, Trackwise desirable
- 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
