Data Scientiste
3 weeks ago
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
The Production Compliance Manager is a detail-oriented and results driven individual with a strong understanding of biologics manufacturing, cGMPs, root cause analysis, and possesses exceptional technical writing skills. The incumbent is responsible for leading Deviation/Non-Conformance Investigations, executing continuous improvement initiatives, leading Change Controls on behalf of the Flu Operations team, and ensuring Shop Floor compliance.
Responsible for critical, major, and minor deviations associated with the Platform:
· Focusing on the Downstream operations (Eggs receiving, Inoculation, Incubation and Harvest), determine the scope of the investigation by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate in real time on the shop floor.
· Lead and develop an investigation strategy in collaboration with Manufacturing, Quality Operations, and SMEs.
· Perform Root Cause Analysis by conducting Shop Floor Production Walkthrough (GEMBA), select appropriate analytical tools, collect, and analyze data to determine the true root cause.
Identify expertise required for the investigation (MSAT, Process Engineering, C&Q, Technical Services, QC, QOVS, QOSA, etc.), p>
· Review and provide guidance on reports prepared by technical staff.
· Support investigation of non-conformances during project phase, identify root cause, and work with the team to identify and implement appropriate corrective actions.
· Support shop-floor execution of Engineering/Development/Process Performance Qualification (PPQ) and Environmental Monitoring Process Qualification (EMPQ) protocols, as needed.
· Initiate and manage change control requests affecting the B200 Flu Manufacturing department.
· Ensure timely closure of change controls.
· Track and monitor change control progress.
· Initiate CAPAs in the Quality System as required.
· Work with Platform Leaders to identify and develop process improvements to remediate risks.
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