To acquire knowledge and be knowledgeable in those parts of the Principles of GLP which are applicable to involvement in the study.
Should have the awareness for the basic principles of OECD GLP.
Design, plan, and monitor in vivo and in vitro genetic toxicology studies (AMES, Cytotoxicity, Micronucleus test, Comet Assay, Chromosomal test, HPRT, MLA studies, etc.,) in accordance with regulatory guidlines(e.g.,OECD, ICH, EPA, ISO).
To scientifically conduct the non clinical safety studies in compliance with the Principles of GLP, regulatory guidelines and animal welfare guidelines like CPCSEA.
Record and maintain study data in accordance with ALCOA+ and data integrity standards.
Handle cell cultures, bacterial strains, and appropriate laboratory models as per the assay requirements.
To take part and monitor the studies related activities like study designing, study plan writing, experimental procedures, data recording and analysis, report writing and archiving.
To act as the single point of control for genetic toxicology studies and take the responsibility for the overall scientifically conduct of studies in compliance with the principles of GLP, regulatory guidelines.
To ensure for recording raw data promptly and accurately and in compliance with the Principles of Good Laboratory Practice and for the quality of the data.
To coordinate for preparation of SOPs of new instrument and studies of in vitro and in vivo Genetic toxicology/microbiology
Ensure GLP compliance in outsourced studies (CRO management).
Prepare and deliver presentations to internal teams and regulatory authorities.
Keep updated on regulatory guidelines (FDA, EMA, OECD, ICH, WHO and ISO).
To plan, perform and execute the studies by active involvement at every stage of the study.
