Core responsibility related to GLP: Study Personnel (Toxicology & Efficacy studies) - Record raw data accurately and directly and in compliance with Principles of GLP during conduct of activity, verify the data collected, prepare reports and archive these records. - Request for test and reference item and its receipt, safe handling and disposal as per in-house SOPs. - Preparation and labelling of reagents, solutions chemicals and testing samples in the laboratory areas - Wearing appropriate protective clothing and follow all safety precautions - Operation, calibration, cleaning, labelling and maintenance of instruments used for routine activity and maintain these records - Maintain cleanliness of the area/section. - Procurements of materials for conduct of experimental activity in laboratory. - Request for controlled documents and maintain accountability as per in-house SOPs - To co-operate during internal, RQA & sponsor audits of study plans, studies, data, reports and facility etc. - Preparation of SOPs relevant to activities performed in laboratory area, conduct the training on SOPs - Follow the instructions given in SOPs and study plan. - Document the deviation from study plan & SOP and communicate directly with SD. - Maintenance of internal records as per in-house SOPs and GLP - Update and maintain training records - Ensure the availability of various monitoring certificates such as feed, water, bedding material, health etc. - Literature search for the studies - Perform the study activities listed below but not limited to: - Feeding, watering, cage changing and other husbandry practices - Weighing of animals - Randomization of study animals - Dose preparation & dosing of animals - Observe the study animals for clinical signs, neurobehavioral and functional observation battery and mortality - Measure and record the body temperature - Perform Draize observations and other dermal observation - Collection of sample(s) / Specimen(s). - Receipt, storage and handling of chemicals, reagents and solutions - Participate in mutagenicity / genotoxicity studies - Participate in standardization of new toxicity study - Perform room activities like recording of room temperature, humidity, lux etc. - Fogging of rooms - Data entry from raw data to computer application and further analysis including statistical programs - Preparation of raw data file, reports and specimen for archiving. Allied responsibility: - Following GPCB guidelines for waste management system and maintenance of its records - To ensure pest control at test facility - Performing assigned duties on weekly off and holidays based on requirements - Create purchase request for material and follow up Any additional responsibility / activity as and when assigned by management which would not arise any conflict of interest.
