- Creation and validation of test protocols for new or existing software following the SLC (System Life Cycle)
- Responsible for characterization as well as execution of lab experiments in accordance with the quality system.
- Responsible for processing and analyzing data using JMP for process monitoring.
- Support test lab with their day to day activities with special attention to process monitoring, validation, equipment support, along with CAPA related activities.
- Initiate design and document change procedures to revise and update new as well as existing documents.
- Extensive knowledge of Good Lab practices and Good Manufacturing practices.
- Involved in clinical observation and health monitoring of laboratory animals such as mice (including transgenic), rat, rabbit, and guinea pig as per FELASA and CPCSEA regulations and AAALAC specifications.
- Carried out the handling, restraining, blood collection, dosing, anesthesia, euthanasia of laboratory animals.
- Had exposure in surgical procedures of laboratory animals (Jugular vein cannulation, Bile duct cannulation, and bile duct ligation).
- Conducted sentinel programs and postmortem studies
- Carried out IFA, ELISA, and parasitic screening procedures in laboratory animals.
- Involved in diagnostic techniques of parasitic diseases of animals.
- Preparation/review of SOPs and guidelines as per specified standards.
- Professional internship in a world-class genetics lab with an international team of scientists
- Performed cutting edge genetic engineering techniques on cultivated yeast samples to understand cancer growth mechanisms
- Monitored facility environment, room activities, and instrument maintenance.
- Trained and supervised workers who handle or care for animals.
- Have worked as a Project Manager for Method Development, Method Transfer, Method Validation, Sample analysis and Report Preparation for Immunogenicity Assessment (Screening, Confirmatory and Titer) and Pharmacokinetic/ Toxicokinetic(PK/TK) analysis for novel and biosimilar biologics in support of non-clinical and clinical studies as per GLP and GCLP compliance on ELISA and ECL Platforms.
- Experience in validation of method transferred Onsite and Paper Transfer by International and National clients.
- Manage inventories of study related test items, critical reagents and qualify them as per the requirement.
- Effective communication with clients in terms of project update, technical discussions, and deliverables of the program.
- Plan, Coordinate and Oversee the study with Analysts, QC, QA and Test facility management to ensure timely delivery of study data.
- Experienced in preparation of Standard operating procedures for the general laboratory operations, Equipment operation, and analytical methods.
- Responsible for Watson LIMS deployment and Validation as per the requirements of 21CFR part 11.
- Core Member of the verification team for point of care diagnostic products.
- Creation and verification of protocols and reports across numerous assays for execution by the operation team.
- Extensive use of software such as JMP and Minitab for data analysis and graphical representation of data.
- Worked efficiently with cross functional teams such as quality, regulatory, operations.