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Online Resumes with "21 CFR 11"



QA Manager, Boca raton, FL

To obtain a position where my education and experience and previous work history would help the firm. I am knowledgeable and have worked with 21 CFR 11, 210 and 211.I was responsible for all 3rd party audits; was the responsible head for all FDA audits and responses; headed the CAPA and OOS Investigations and was involved with International Regulatory submissions as well as all FDA submissions. I was resopnsible for all OO...

Tags for this Online Resume: Quality Assurance, Quality Control, Manufacturing, Teaching, Bio-Statistics, Regulatory

Clinical Project Manager, Sacramento/San Francisco, CA

Tags for this Online Resume: Project Management, Monitor, GCP-ICH, FDA, Clinical Research, Patient Safety, 21 CFR 11, Data Management, Budget and Forecast Planning

Quality Manager - 20 Years of Experience - Near 37129

SUMMARY * Conduct medical device, cosmetic and pharmaceutical excipient and APIs, and supplier certification, evaluation and qualification activities, including on-site and desktop assessments of quality systems, product and process controls develop control plans for monitoring supplier corrective actions for quality, performance and delivery, employing standard industry tools (pFMEA, root cause investigation, lifecycle man...

Tags for this Online Resume: Instrumentation, Diagnostics, ISO, ISO 9001, Management, Document Management, Software, Assessments, Engineering