efficient, timely, batch record review and CGMP compliant materials and products release. Support and represent QA... as required, Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies...
efficient, timely, batch record review and CGMP compliant materials and products release. Support and represent QA... as required, Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies...
. Participate in risk assessments to define qualification/validation requirements. Perform QA reviews of system impact assessments... and equipment categorization. Act as the QA point of contact for discrepancy, deviation, CAPAs, and change controls related to C&Q...
expert in projects for qualification related issues, under direction of a project manager or Head of Quality. Drafts... and / or performed by others). Assesses independently whether equipment / systems should be qualified and reviews this with QA...
, under direction of a project manager or Head of Quality. Drafts/Reviews Validation/Qualification Project Plans and Validation... / systems should be qualified and reviews this with QA. Assesses by others within ES or by external companies established...
to enable Roche’s expanding in Shanghai with growing Drug Product operations, the role of Engineering Quality Manager for a new... project quality team, this position report to Quality Head of Biologics, has overall responsibility for participating...