The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Scientist II, RSL
Job Description
Brief Job Overview
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.
• Executes analytical tests as assigned by the Project Leader or Group Leader.
• Ensures project completion within timelines and troubleshoots scientific issues as needed.
• Coordinates with the group leader to ensure team projects are completed.
• Manages sample archival, sample tracking, and chemical inventory in the laboratory.
• Ensures availability of chemicals and columns for projects and forwards purchase requisitions.
• Performs equipment calibration as per the schedule.
• Prepares, executes, and completes IQ/OQ/PQ of new instruments.
• Prepares and reviews SOPs, protocols, and reports.
• Conducts initial reviews of project reports and documents, assisting the group leader when required.
• Takes on additional responsibilities assigned by the group leader as needed.
• Maintains lab safety and GLP practices, and actively participates in internal and external audits and certifications.
• Follows QMS protocols and handles incidents and deviations.
• Supports Verification, GPH, PQM, stability, and other departmental teams with testing and project reviews as needed.
Candidate Profile
• Experience : Master’s degree in M.Sc. (analytical or organic), M.Pharma (pharmaceutical sciences or analysis) with 3 to 6 years relevant laboratory experience.
• Proven track record of consistently in completing the tests on time, with high quality for formulation and API’s.
• Proficient in chromatographic analysis, particularly in HPLC and GC.
• Proficient in handling other related analytical instruments such as Auto titrator, KF, FTIR, UV spectrometer, Thermal equipment’s, Elemental analyzer, SOR, TLC etc.
• Proficient in wet chemical analysis.
• Must possess effective communication skills, both written and verbal.
• Expert in Empower software with knowledge on Audit trails and Custom fields.
• Must possess good technical and analytical skills to independently resolve or troubleshoot issues.
• Should have a strong understanding of GLP regulations and exposure to external regulatory audits.
Additional Desired Preferences
• Having knowledge of Lab Management System (LMS) and Electronic Laboratory Notebook, ERP, QR coding system is an added advantage.
• Hands-on experience in handling instruments like MS is an added advantage.
• Understanding monograph procedures and participating in compendial methods for reference materials (USP, FCC, NF, etc.).
• 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.
• Awareness of ISO/IEC 17025 is desirable.
Additional Information
Experience : 3 to 6
Qualification : M.Pharm, M.Sc
Location : Hyderabad, IND
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 5th May 2025
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