promeatherapeutics
Job responsibilities: To ensure the daily operations of analytical lab in ARD Department. Responsibility to analytical method development, validation, and routine testing. Manage release and stability testing of raw materials, in-process, and finished products on time. Preparation of validation protocols and reports as per USFDA, EMA and ICH guidelines. Ensure the lab instrument calibrations and maintenance as per the in-house protocol. Responsible for implementation of GLP activities in ARD lab. Responsibility to verify the all log books on daily basics. Preparation standard operating procedures in ARD Lab. Responsibility to ensure the sample management system in ARD Lab. Responsibility to ensure the lab cleanness in ARD lab. Initiation and closing of incidents, VIRs and Change controls in ARD lab. Ensure the qualifications of lab instruments in ARD lab. Responsibility to coordinate with the vendors to resolve the instrument related issues. Perform the development, validation, stability and support analysis on priority basis. Preparation of specification, test methods, standard testing procedures in ARD lab. Responsibility to assign the AR Numbers to testing samples from FRD or Third party. Responsibility to loading and withdrawal of stability samples as per the protocol.