Quality Assurance Specialist

Purpose
The Quality Assurance Specialist within the 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

Responsibilties

• 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

• 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

The position is onsite and remote or hybrid is not applicable for this role.
This is a shift position - 4 cycle - 12 hours per shift e.g

• 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