Quality Assurance Specialist (shift)
RK24327
Contract 11 months
Carlow




We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



The Quality Specialist is a member of a team within Global Development Quality (GDQ) and is involved in supporting the GMP Quality Assurance activities for the GDQ IMP Licence.



Key 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
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

• Minimum qualification B.Sc. or M.Sc./ M.Eng Engineering or Science discipline
• 2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
• Knowledge of cGMP and GDP essential Report, standards, policy writing skills required
• Competent in the use of MES, Trackwise and SAP