Description
Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document control corrective and preventive actions training customer returns recalls validations annual product review and technical files from scratch to meet FDA 21 CFR 820 210,211 regulations Health Canada regulations and ISO-13485:2003 regulations at different roles. Wrote 400 procedures in four years for different functions for meeting regulations related to manufacturing packaging and distribution. Trained 200 employees and Senior Management for upgraded procedure. Trained employees for ten different cGMP modules for the last ten years. Maintained Establishment license and product licenses for distribution in different countries. Maintained Accreditation of analytical laboratories. Maintained calibration and preventive maintenance program to support validation. Approving Cleaning Validation Protocols / Stability Protocols/ Design and process validations * Approving out of specification results * Conducting Internal and External Auditing Contract Manufacturing * Conducting Training and Development Program * Managing Instrument Calibration Program * Linking Document Control to training * writing AQL Sampling * Developing Budget * Approving Batch Records Change Controls CAPA and Deviations * Guiding analytical Method Development and Validations * Clinical Study Coordination * Writing Technical files for medical devices * writing Annual Product Reviews for Drugs
Accomplishments
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