Quality Shift Specialist

Vor 7 Tagen


City of Melbourne, Österreich CSL Vollzeit

Overview Join CSL’s Quality Assurance team at our Tullamarine site as a Frontline QA Shift Specialist . You’ll work closely with manufacturing and operations teams to ensure GMP compliance during real‑time production of influenza vaccines and other life‑saving products. This is a rotating 12‑hour shift role (6 AM–6 PM / 6 PM–6 AM) with a 7‑shift fortnight pattern alternating between day and night shifts. Reporting to the QA Shift Manager, this role is critical to maintaining product quality. Responsibilities Provide on‑floor QA oversight during manufacturing and related operations. Perform GMP walkthroughs and real‑time review of electronic batch records (MES). Approve usage decisions in SAP and ensure compliance during production. Act as QA representative during troubleshooting and escalating issues as needed. Manage and approve deviations and CAPAs and support SOP and GMP document updates. Qualifications Experience in a pharmaceutical or biotech QA or manufacturing environment. Strong background in deviation management and risk‑based decision‑making. Familiarity with GMP regulations and electronic systems (MES preferred; SAP advantageous). Ability to work rotating 12‑hour shifts and operate independently on the shop floor. Benefits CSL Seqirus offers a comprehensive benefits package and a culture that values inclusion and belonging. #J-18808-Ljbffr



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