The U.S. Pharmacopeial Convention (USP) 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 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Scientist II, RSL
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.
• Executing the analytical tests allotted by Project Leader or Group Leader.
• Responsible for completing the project as per the timelines and troubleshoot the scientific aspects of the projects on need basis.
• Coordination with group leader to ensure completion of the projects allotted to the team.
• Responsible for sample archival, sample tracking and chemical inventory tracking in the laboratory.
• Responsible for the initial review of the project reports, documents and assisting the group leader when required.
• Taking up any additional responsibilities assigned by group leader from time to time.
• 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.
• Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.
• Responsible to maintain and follow QMS and should handle incidents and deviations.
• Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing and project review whenever needed.
• Must have a 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, 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.
• Should have knowledge of Empower software.
• 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.
Experience : 3 to 6 years
Qualification : M.Sc, M.Pharma
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 20th October, 2023
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