Executive, R&D-Analytical Development Laboratory

Job Description

Perform analytical method development, method validation and query response for the finished product. Prepare analytical method development reports, CDP and COA (Certificate of Analysis) Perform and review analysis of In-process sample/Finished goods/ Stability samples and related documentation as per cGMP requirement. Monitoring general laboratory and its maintenance activity as applicable. Responsible for performing routine analysis and stability analysis of the finished product for assay, CU, related substances, dissolution and residual solvent etc. Prepare draft STP. Review of analytical data, calibration data and qualification data Responsible for troubleshooting and maintenance of HPLC, GC, UV/Visible and spectrophotometer etc. Calibration of analytical instruments like Analytical Balance, pH meter, UV spectrophotometer, KF Potentiometer, Karl Fischer as per the schedule. Following in house systems and procedures to ensure cGMP practices and regulatory requirements. Maintenance of reference standard, working standards and their standardization. Co-ordinating the activities in Chemical and Instrumentation. Handling of Troubleshooting. To update instrument log book entries Desired Skills: Must have experience in formulation testing in reputed pharma organizations. Handling of instruments like HPLC, GC, UV, UPLC, Dissolution tester, KF, FTIR. Strong knowledge of Microsoft Word/Excel.PPT. Good Communication and problem solving skills. Should be assertive, proactive and self-driven. Should be willing to work in a dynamic work environment. Pedigree: B. Sc (Chemistry), M.Sc (Chemistry) with 3-5 years of relevant work experience.