Analytical Chemistry-Analyst
2 weeks ago
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
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