Research scientist-II
Apotex
Total years of experience :13 years, 8 Months
• Analysis of stability products as per ICH Guidelines.
• Analysis of stability products such as Injections, tablets & capsules as per required pharmacopeia guidelines.
• Preparation of COA’s.
• Preparation of stability summary sheets.
• Receive the sample from production/Quality assurance dept., Verify quantity received, label and details against the test request form, ensure storage after appropriately logging the details in AR register/LIMS, file documents in appropriate QC file as per current procedures.
• Print/obtain the raw data sheet from LIMS/supervisor for the sample allotted along with the sample.
• Analyses all the tests allotted as per current specifications, standard test procedure and general procedures.
• Send samples to approved outside testing lab for analysis as per current procedure.
• Ensure that all analytical activities performed are recorded concurrently in Raw data sheet/test request form as applicable.
• Record details such as instrument usage, analytical standards, column entry of analysis in the relevant log books/ registers/ LIMS etc., concurrently.
• Attach all raw data such as Balance printout, instrument printouts after promptly labeling these printouts as per the current procedure.
• Record the data from each test in LIMS/calculate the results as per current procedure.
• Ensure all the analytical data are compiled along with executed raw data sheet as per current procedure and submit to supervisor for review.
• Report any OOS/OOT/aberrant results observed to superior immediately, retain the samples/solutions on such observation and participate in the investigation.
• Perform IT enabled transactions (such as LIMS, Track wise, Documentum) wherever applicable in an accurate and timely manner as per current procedures.
• Perform destruction of left over samples safely and document as per current procedure.
• Handover completed analytical documents to QA.
• Calibrate the all necessary instruments such as balance, pH meter, conductivity meter and TOC instruments as per requirement.
• Review of TRF analytical records of in-process and water reports on need basis.
• Carry out any activities assigned by supervisor to relevant employees.
• Promptly report if any incident(s) is observed per the current procedure and bring it to the attention of the supervisor.
• Review of analytical records, external reports, as per current procedure.
• Qualification of working standards, In-house reference standards as per current procedure.
INSTRUMENTS HANDLED
• HPLC (Agilent-1100 & 1200 Series system with Chromeleon software, Waters system with Empower 3 software & Shimazdu system with LC Solutions software).
• UV-Spectrophotometer.
• Karl Fischer Autotitrator.
• Particulate matter Analyser.
• Total Organic carbon Analyser.
• Dissolution Apparatus.
• Disintegration & Friability.