Rajender Reddy Sama.
Assistant Manager @Axis Clinicals Ltd
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WORK HISTORY
Assistant Manager @Axis Clinicals Ltd
Hyderabad, IN
PRIMARY RESPONSIBILITIESEnsure that all processes contributing to the performance of a clinical trial are conducted properly.Troubleshoot clinical trials and activities.Manage and maintain databases for the quality system.Prepare and assist in preparing annual reports and quality trending reports.Report the status of the quality levels of staff, systems and production activities.Preside over improvement programs.Evaluate quality events, incidents, queries, and complaints.Keep up to date with all related quality legislation and compliance issuesCompile and prepare materials for submission to regulatory agencies.Document internal regulatory processes.Ensure regulatory rules are communicated through corporate policies and procedures.Utilize guidance documents, international standards, or consensus standards and interpret for guidance.Ensure that investigator, vendor, facility and system audits are conducted.Communicate any critical compliance risks noted from these activities to senior management.Assume a lead role for the preparation, conduct, and responses to regulatory agency.Provide leadership and strategy in line with global strategic objectives.
EDUCATION
JNTUH
PhD Registered, Pharmaceutical Sciences (Pharmacology)
Biomed informatics,Medwin Hospitals,Hyderabad
Post graduate diploma in, Clinical Trials
Rajiv Gandhi University of Health Sciences
Bachelor of, Pharmacy
Annamalai University
Master of Pharmacy, Pharmacology
SKILLS
ABOUT RAJENDER REDDY SAMA.
A Post graduate in Pharmacy (Pharmacology), who holds P.G diploma in Clinical trials…
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