Regulatory Affairs And Quality Assurance Associate
CurrentAs the Regulatory Affairs and Quality Assurance Associate, I am responsible for:Regulatory Affairs:- Reviewing and submission of CTD dossier on the PPB portal.- Responding to product screening query responses.- Conducting timely visits to the PPB board to follow up on the registration status of products- Advising foreign principals on the categorization of variations as per the PPB variation guidelines and uploading the same on the portal.- Filing and submission of variations Quality Assurance:- Review of existing and preparation SOPs to match the most current statutory guidelines and also to suit current processes- Ensuring that warehousing operations are conducted as per the existing SOPs and statutory guidelines- Training of warehouse personnel on Good Distribution Practices and Standard Operating Procedures- Ensuring that all the instruments/equipment used are calibrated on time- Ensuring all the storage facilities are qualified: carrying out mapping and validation exercises- Handling of USAID dawa za ubora project where; I ensure that the commodities are received, and stored in an orderly manner ensuring none is damaged.- Reviewing warehouse temperature and humidity daily reports and ensuring that they are within the recommended limits.- Conducting Root Cause Analyses for any deviations observed and coming up with suitable corrective and preventive actions.