Key Responsibilities
- Assist in the conduct of the study in compliance with the Principles of Good Laboratory Practice.
- Operating analytical equipment and ancillary equipment
- Compliance with the study plan and Standard Operating Procedures applicable to their involvement in the study.
- Recording of data with compliance to ALCOA+ principles
- Documenting and communicating and deviation to supervisor/team lead/study director
- Ensuring health and safety practices at the workplace
- Communicate with Management, QAU, Document Controller, TICO, and Archivist as per the Study Director’s instructions.
- Verify the calibration and maintenance of the instrument/equipment before the start of the experiment.
Educational Qualification
- M.Sc./ M. Pharm in Chemistry
Technical/Functional Skills
- Experience/awareness of analytical and bioanalytical studies.
- Knowledge of different extraction techniques.
- Ability to handle analytical and ancillary instruments viz GC, UPLC/HPLC, LCMS, Solo VPE, pH meter.
- Review of calibration and maintenance records
- Calibration and use of micropipettes
- Using MS office, especially Microsoft Excel
- Documentation logbooks and raw data for activities performed without any errors.
- Knowledge of regulatory requirements, practices, and guidelines like OECD, USFDA, EMEA, ICH etc.
Experience
- 3-6 years in the relevant regulated environment
Behavioral Skills
- Good communication skill, both verbal and written
- High level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment.
- Ability to work successfully in a dynamic, ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
- Ability to develop new ideas and creative solutions.