Experienced QA Professional with strong knowledge and expertise in document management/ document Control ,archiving,GCP, GDP, and GMP regulations, implementation of EDMS systems, data integrity,go live support and training. Expert in Veeva Quality docs, Master Control, Share point, Aconex.
Assisted in file migrations and regulatory audits, Expert in CRF, Standard Operating Procedures (SOPs) review , NCR, batch review, change management and deviations, label printing and reconciliation .Training employees in eQMS,GDP,managing and updating all training files for the organization.
Strong knowledge of current Record and Information Management ,ICH Guidelines, Health Canada Food and Drug Regulations, Health Canada Guidance for Clinical Trial Sponsors: Clinical Trial Applications and other Canadian requirements as they relate to pharmaceutical, biological, and medical device product development