Research Assistant and Quality Assurance Officer with extensive experience in document management, statistical analysis, and regulatory compliance. Proven success in quality research monitoring, data analysis for clinical applications, and preparing comprehensive reports and presentations. Bringing strong problem-solving skills and dedication to advancing research and quality standards.
● Organized, edited, and disseminated documents and materials drawn from various sources for research.
● Monitored standards for quality research and project timelines
● Tuned the analysis used in clikJaundice to be sufficiently robust for clinicians to automatically respond to monitored data forwarded by clinicians at several hospitals in India.
● Tested clikJaundice with real data from a variety of hospitals and compared with bilirubin levels measured locally
● Aided in collecting data from many hospitalized neonates and updating the database
● Analyzed the information updated in the database with the normal Bilirubin values
● Assisted in planning and organizing project team meetings and team functions
● Prepared reports of completed projects for publication in technical journals
● Created presentations of research work for an agency requesting project.
● Prepared comprehensive reports summarizing research findings.
● Maintained a database of all research activities conducted during the course of each project.
● Controlled document movement, retrieval and issuance of documents like SOP, ROA, Batch records etc
● Coordinated the QA Team and also with other departments for audit preparedness
● Emailed and called the department heads for SOP revision and QMS meetings
● Retrieved and stored documents like Batch Records, Logbooks, etc
● Processed Document Change Request of every department through change request form and revision of documents
● Backed up system master files every week consecutively for 3 months
● Number allotment for master documents and equipment
● Followed -up with different department heads for the timely revision of SOPs.
● Packing In process quality Assurance activities
● Prepared Annual Product Quality Review of several products
● Labelled and prepared the QA document storage room for archival of documents from different departments
● Maintained document tracking system and responded to correspondences from different departments upon request
● Prepared and compiled process validation and hold time study protocols and reports
● Issued SOP, STP, ROA, Specifications, Logbooks, Batch records etc.
● Controlled the document movement within different departments
● Retrieved and archived documents
● Coordinated QMS meetings to assess the performance of different departments and got suggestions for improvements in work procedure and flow
● Number allotment for master documents and equipment
● Handled vendor documents
● Performed other duties assigned by QA manager.
● Organized, edited, and disseminated documents and materials drawn from various sources for research
● Monitored standards for quality research and project timelines
● Tuned the analysis used in clikJaundice to be sufficiently robust for use by clinicians to automatically respond to monitored data forwarded by clinicians at several hospitals in India
● Tested clikjaundice with real data from a variety of hospitals and compared with bilirubin levels measured locally
● Assisted in planning and organizing project team meetings and team functions
● Prepared reports of completed projects for publication in technical journals
● Created presentations of research work for agency requesting project.
Full time