Junior Executive, R&D-Analytical Development Laboratory (ADL)

Job Responsibilities

• 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