Analytical Chemistry-Analyst

Core Purpose of the Role:

This role involves method development, method validation, method transfer and R&D stability studies by using laboratory instruments like Ultra performance liquid chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, Polarimeter, etc.

Role Accountabilities:

• Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product.
  • Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers
  • Shall have experience on Good documentation/laboratory practices such as ALCOA+
• Experience in calibration and qualification of HPLC, UPLC, GC, and other QC laboratory instruments
  • Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures
  • Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control)
• Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects
  • Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure
  • Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity
  • Good communication and e-mail writing skills are required since the candidate needs to communicate to client/external users situated overseas