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Sterility Assurance Lead, CVRM (Holly Springs) @ Genentech

Holly Springs, North Carolina, United States of AmericaOnsiteFull-time
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About this role

Exciting opportunity for a Sterility Assurance Lead to shape the future of drug manufacturing at Holly Springs, NC. Drive sterility assurance strategy, lead aseptic program development, and ensure compliance with global standards. Join a high-impact team at the forefront of innovative, greenfield pharmaceutical manufacturing. Make a difference in patient safety and quality.. Category: Regulatory & Quality

Skills

sterility assuranceaseptic processingcontamination controlcgmp complianceaseptic process simulationsterilization equipment qualificationgood manufacturing practicesglp compliancefda regulationseu annex 1 complianceroot cause analysiscorrective and preventive actionsenvironmental and personnel monitoringmaterials qualificationtraining program development

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