QA Specialist
Orion Group View all jobs
- Carlow
- Contract
- Full-time
- 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: Wednesday and Thurs Nights
- Shift premium is 33%
- The position is onsite and remote or hybrid is not applicable for this role,
- For the job shift experience, working in a quality function or in an aseptic environment is beneficial
- 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 e.g. 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
- 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.
Reports to Quality ManagerQUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
Skills and Knowledge
Typical Minimum Education
- Bachelor's Degree or higher preferred in a Science discipline
- 1-2 years' experience in a Quality Role at pharmaceutical manufacturing
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