Sr. Process Validation Scientist
Sr. Process Validation Scientist (Former Employee) – Puerto Rico – 20 April 2016
• Designs and conducts technology transfers and process validation activities for oral solid drug dosages (OSD) products.
• Prepares documented protocols and reports for validation exercises in compliance with corporate guidelines, procedures, FDA Regulations and industry current practices.
• Prepares assessments to support that validated critical process and operational parameters are within qualified parameters for specific oral solid drug dosages (OSD) products. Identify and propose equipment enhancements to support intended process operational ranges.
• Determines the needs and coordination for Placebo and Experimental testing materials for validation and performance qualification studies.
• Identifies, plans, and implements quality/productivity initiatives associated to process validation and performance qualification activities based on business needs and priorities.