United States Pharmacopeia Hiring RSL Scientist

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Post : Scientist II, RSL

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
• Executes all testing and analysis of data with excellence and essentially no errors.
• Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing whenever needed.
• Responsible for sample archival, sample tracking and chemical inventory tracking in the laboratory.
• Coordination with supervisor to ensure completion of the projects allotted to the team.
• Completing the project as per the timelines and troubleshoot the scientific aspects of the projects on need basis.
• 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 Supervisor 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.

Candidate Profile
• Master’s degree in chemistry or Pharmacy.
• 3 to 6 years with relevant laboratory experience.
• Proven track record of consistently delivering projects on time and with high quality for API’s.
• Expert in chromatographic analysis, particularly in HPLC.
• Proficient in other related analytical instrumentation such as Water determination, Loss on drying, Residue on Ignition, Titrations, Spectroscopic analysis (UV, IR etc.,).
• Knowledge of pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP compendia, ICH guidelines, FDA regulations etc.).
• 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.
• Knowledge in other related analytical instruments (GC, Thermal, Elemental analysis, Mass analyzers etc.), Electronic Laboratory Notebook, ERP, QR coding system will be 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 GLP regulations, QMS, ISO/IEC 17025 and exposure to external regulatory audits is desirable.
• Ability to embrace and lead change. Extremely adaptable.

Additional Information
Experience : 3 to 6 years
Qualification : Master’s degree in chemistry or Pharmacy
Location : Hyderabad, IND
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 15th December 2024