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