The U.S. Pharmacopeial Convention (USP) Scientist III - Reference Standard Laboratory in Hyderabad, India
Scientist III - Reference Standard Laboratory
U.S. Pharmacopeial Convention (USP) is a scientific non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP promotes Diversity & Inclusion at Workplace and encourages Equal Employment Opportunity and Affirmative Action
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 Leader 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 archival, sample tracking 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 SOPs, 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.
- 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 and troubleshooting, proficient in other related analytical instrumentation (Titrations, IR, KF, UV, Thermal, Elemental analysis 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, ELN, ERP, QR coding system are added advantages. Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
- Ph.D. in Chemistry with 3-4 years or master’s degree in chemistry with 5-7 years of relevant laboratory experience.
Job Category Scientific