Information about the Role:
Qualifications:
Day-to-Day: One of our large pharmaceutical clients is looking to hire a Quality Person In Plant to join the growing External Quality team within Advanced Therapeutics. This individual will be providing Quality oversight of the analytical space. Main responsibilities will include:
-Review and approve nonconformances and deviations out of specification.
-Interface as liaison internally and externally for review/approval/implementation of change controls.
-Support monitoring of EM quality performance and proactively identify risks.
-Influence and build relationship with internal and external partners to continuously enhance quality performance.
-Interface with other functions i.e. Operations, Planning, Technical Operations, etc. as well as the external manufacturer
-Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
-Provide on-site support as needed on request of the team lead
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