Orion Group Life Sciences are currently recruiting a
Quality Assurance Specialist (Shift)
on behalf of our Multinational Biopharmaceutical Client based in Carlow on an 11-Month contract.
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: Wednesday and Thurs Nights
* Shift premium is 33%
Role Overview
The Quality Assurance Specialist is required to:
* Work a 4-shift pattern role
* Possess technical knowledge of sterile manufacturing processes
* Perform timely reviews of batch documentation, investigations, and reports, highlighting and assisting in the resolution of concerns commensurate with risk
* Respond quickly to unplanned events and technical issues
* Demonstrate operational experience with quality systems in a dynamic manufacturing environment (e.g. SAP, Trackwise, MES)
* Have a full understanding of relevant quality and compliance regulations, including knowledge of requirements for cGMP and both US and EU regulatory standards
* Conduct, report, and display Quality Right First Time and audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
* Support the spot check and walk-through processes of production lines
* Participate in customer complaint investigations as required
Additional Responsibilities
* Provide Quality support to production teams to ensure cGMP standards are consistently maintained
* Understand sterile manufacturing operations (preferred)
* Learn and utilize computerized systems to perform daily tasks
* Prioritize and manage multiple tasks to meet defined deadlines
* Review batch documentation (e.g. Electronic Batch Records), perform line clearances, and assist in resolving concerns
* Liaise with other departments to promote improvements in GMP and Quality standards
* Comply with all relevant Quality and EHS Management System requirements as applicable to commercial operations
Qualifications & Experience
Education
* Bachelor's Degree or higher preferred in a Science discipline
Experience
* 1–2 years' experience in a Quality role within a pharmaceutical manufacturing environment, preferably sterile/aseptic manufacturing
* Experience using systems such as SAP, MES, and Trackwise (desirable)
* Strong technical writing and documentation skills
* Working knowledge of applicable Irish, European, and international codes, standards, and practices
* Solid understanding of cGMP and GDP requirements
* Competency in the use of MES and SAP systems