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Online Resumes with "21 CFR Part 58"



Quality Assurance Auditor - 12 years Experience - Pharmaceuticals

Quality Assurance Auditor with proficient skills and experiences in various compliance disciplines. Have a passion to conduct local, international, and global audits, training, and provide guidance services within the following regulatory specialties: â?¢Good Laboratory Practices (GLP) 21 CFR Part 58 â?¢Good Clinical Practices (GCP), VICH GL9, Document 85 â?¢Environmental Protection Agency GLP (EPA-GLP), 40 Code of Federa...

Tags for this Online Resume: Auditor, GLP, GCP, Quality Assurance, QA Manager, QA Auditor

Not Listed - 20 Years of Experience - Near 07936

SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...

Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist

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Clinical Regulatory Affairs - 20 Years of Experience - Near 53143

Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...

Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices