The U.S. Pharmacopeial Convention (USP) Scientist II in Hyderabad, India
Summary of the Position:
- This is a non-supervisory position in Reference Standard Laboratory responsible for performing the required tests as part of the project and maintaining the GLP environment in the Laboratory. The incumbent will utilize his or her technical expertise, knowledge of pharmaceutical analysis in collaborative testing, efficient and effective laboratory operations.
Roles and Responsibilities:
Executing the analytical tests allotted by Project or Group Leader.
Verification of test protocol and giving test kit approvals, if required.
Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing and project review whenever needed.
Responsible for preparation of project evaluation reports.
Responsible for sample tracking, sample archival and chemical inventory tracking in the laboratory.
Coordination with group leader to ensure completion of the projects allotted to the team.
Initial review of the project reports and documents and assisting the group leader when required.
Completing the project as per the timelines and troubleshoot the scientific aspects of the projects on need basis.
Responsible for preparation and review of SOP’s, protocols, reports etc.
Responsible for performing the calibration of the Equipment as per the schedule.
Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.
Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.
Taking up any additional responsibilities assigned by group leader from time to time.
Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.
- Ph.D. in Chemistry or Master’s degree in chemistry or Pharmacy.
2 to 3 years with relevant laboratory experience for Ph.D. candidates.
5 to 7 years with relevant laboratory experience for Master’s degree candidates.
- Proven track record of consistently delivering projects on time and with high quality. Proficient with pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP, FCC, NF, etc.). Expert in Chromatographic analysis, especially in HPLC, GC, IC and troubleshooting, proficient in other related analytical instrumentation (Mass Spectrometry, Titration, IR, KF, UV, Thermal, Elemental analysis by ICP etc.), Takes personal responsibility for delivery of projects to customers. Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal. Having knowledge of Empower software, Lab Management System and Electronic Laboratory Notebook, ERP, QR coding system are added advantages. Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or Analytical R&D or a contract pharmaceutical analytical laboratory testing organization is a plus.
Job Category Chemistry & Scientific Standards
Job Type Full-Time