jnananda buddharaju

Leading a team to manage the functions of Quality Assurance department of Clinical Unit and Clinical Investigation Unit for regulatory compliance. Develop and manage an internal auditing program that encompasses all clinical phases of BA/BE study. Perform retrospective audits of study specific / operational documentation, identify and report potential deviations and follow up on relevant corrective measure. Review study specific protocols. Coordinate periodic quality management reviews and ascertain compliance status of management. Manage facility and system audits of different regulatory bodies such as USFDA, WHO, Anvisa, MHRA and AFSAAPS. To interpret relevant regulations and apply them to create specific Operational & Quality Assurance SOP’s and policies which adhere to regulatory guidance. Conducting training on Good Clinical Practices and Good Laboratory Practices to all personnel involved in the research.

 To interpret relevant regulations and create specific Operational & Quality Assurance SOP’s in compliance with regulatory guidelines.  Review of analytical method validation and degradation study documents for Drug master filing.  Evaluation of batch analytical reports and in process analytical reports of API’s.  To assist in conducting in-house audits of the Quality control department for GLP compliance.

* Teach Pharmaceutical Analysis and Physical Pharmacy to B.Pharmacy students according to an approved course syllabus * Keep students informed and updated concerning course content, requirements, evaluation procedures and attendance requirements * Conduct student evaluations and complete other college evaluations in accordance with college policy

 Conducting and documenting bio equivalence studies following relevant protocols.  Analysis of clinical samples for quantification of drug concentration on HPLC.

Senior Manager Regulatory Operations at Freyr Solutions