Major purpose of the Job: To ensure that all bioanalytical activity adheres to a defined set of quality criteria or meets the requirements of the client or customer. Responsibilities: -Responsible for answering and response preparation for the sponsor queries. Regular coordination with internal department RQA, Bioanalytical and RA department to ensure the timely resolution of bioanalytical queries received from the regulatory agency. -Regulatory queries and response preparation in the defined timeframe. -Checking of Method validation data -Checking of Bio-study data -On-line checking of logbooks of Bioanalytical Lab. -Responsible for checking of calibration of all instruments in Bioanalytical department -Responsible for SOP preparation and training of SOPs -Preparation and Checking of STP, Protocol, report, SOP -Responsible for on-line checking of all activities in Bioanalytical department -Responsible for documentation -To prepare and review eCTD reports, summary tables for the final submission. -Maintaining GLP in lab -Responsible for the induction of the all newly joined employee. -Procurement of controlled documents from RQA department. -Maintain the accountability records. -Preparation and updating method validation reports and project sample analysis reports. -Preparation and updating method validation Protocol and Bioanalytical Study Plan.
