Job Description

Core responsibility related to GLP Study Personnel (Toxicology, in-vivo mutagenicity and Analytical Laboratory) Follow the instructions given in SOPs and study plan and document and communicate any deviation from these instructions directly to the Study Director HoS. Record raw data accurately and directly 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. Operation, calibration, cleaning, labelling and maintenance of instruments used for routine activity and maintain these records. Perform the study activity of toxicology & in-vivo mutagenicity (except slide reading) & data collection, compilation and verification. Procurements of materials for conduct of experimental activity in laboratory. Preparation and labelling of reagents, solutions and chemicals in the laboratory areas. Data entry from raw data to computer application and further analysis Maintenance of internal records as per in-house SOPs and GLP Cooperate during internal, RQA & sponsor audits of facility or study plans, studies, data, reports etc. To help in standardization of new toxicity & validation study Update and maintain training records Ensure instrument used are calibrated and maintain the records Ensure the maintenance of daily activity records Ensure proper labeling of containers (test item, samples etc.) Preparation, maintenance and implementation of SOPs for various activities and provide SOP training Requesting, receiving, maintaining accountability of the standard formats/controlled documents Ensuring the availability of various monitoring certificates such as feed, water, bedding material, health etc. Provide help for method development and method validation for analysis of various molecules. Provide help for formulation sample analysis as per in-house SOP and study plan. Allied responsibility: Study Director for Non-GLP studies (Efficacy/QC studies) Development of various animal models and its standardization/ validation. Training and orientation of the personnel involved in efficacy/QC studies. Day to day work allocation to the personnel involved in efficacy/QC studies. To help and coordinate with sponsors of efficacy/QC studies for preparation of study plan, draft & final reports, archiving etc., and to help in study conduct. To ensure that SOPs are made available to study personnel and work assigned is performed in compliance with study plan and SOPs. To ensure facilities and materials required for study conduct are made available to the personnel involved in efficacy/QC studies. Preparation, maintenance and implementation of SOPs for various activities To ensure that all the reagents, solutions and chemicals in the laboratory area are labeled and maintained. Procurement of materials and animals for efficacy/QC studies Assure that all staff uses appropriate protective clothing and follow all safety precautions. Maintenance and calibration of instruments / equipment and utilities. Record maintenance related to Pre-Clinical efficacy/QC studies General material procurement. To help in facility maintenance. Communication with finance team, purchase team and suppliers. Any additional responsibility / activity as and when assigned by management which would not arise any conflict of interest.

Skills Required