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 : Senior Scientist I, Reference Standards Laboratory
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.
Job Description
• Executing the analytical tests allotted by Project Leader or Group Leader.
• Responsible for review and approval of the test protocol, test kit assigned by team or group leader if required.
• Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing and project review whenever needed.
• Responsible for mentoring and training juniors in team for day to day activities
• 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.
• Responsible for the initial review of the project reports, documents and assisting the group leader when required.
• Responsible for 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.
• Responsible to maintain and follow QMS and should handle incidents and deviations.
Candidate Profile
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Ph.D. in Chemistry or masters degree in chemistry / Pharmacy.
• 7 to 10 years with relevant laboratory experience for Ph.D. candidates.
• 11 to 13 years with relevant laboratory experience for master’s degree candidates.
• Proven track record of consistently delivering projects on time and with high quality for formulation and API’s.
• Expert in chromatographic analysis, particularly in HPLC, GC, IC, LC-MS, and GC-MS.
• Proficient in other related analytical instrumentation such as Mass Spectrometry, Titration, IR, KF, UV, Thermal analysis, Elemental analysis, etc.
• 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 and Electronic Laboratory Notebook, ERP, QR coding system is an added advantage.
• Hands-on experience in handling instruments like ICP-OES/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. Supervisory Responsibilities No Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Additional Information
Experience : 7-10 years
Qualification : Ph.D or M.Pharm, MSc
Location : Hyderabad
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 20th September, 2023
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