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
Work well cross functionally and be an active team member
POSITION 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 AND 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
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: Wednes and Thurs Nights
Shift premium is 33%
For the job shift experience, working in a quality function or in an aseptic environment is beneficial