Quality Assurance Specialist (shift), Carlow

Quality Assurance Specialist (shift)
RK25863
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 standardsConduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP complianceComply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

Education and Experience:
Minimum qualification B.Sc. or M.Sc./ M.Eng Engineering or Science discipline2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturingKnowledge of cGMP and GDP essential Report, standards, policy writing skills requiredCompetent in the use of MES, Trackwise and SAP


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.