Wear appropriate PPE and follow safety rules precisely.
Follow the cGMP/GLP and Good Documentation practices.
Maintain good housekeeping in the laboratory.
Record the Temperature and % Relative Humidity in the Laboratory and chambers.
Check the Calibration, Preventive maintenance and status tag of the instruments prior to use.
Operate and calibrate the instruments as per SOP.
Perform sampling and wet testing of Raw material, Packing materials, in-process intermediate, Finished products and stability/Hold time as per the work allotment.
Responsible to perform the HPLC analysis of Raw material, in-process/cleaning, intermediate, finished product, stability samples and HPLC monthly PM as per the work allotment.
Responsible to perform PSD analysis.
Enter the test results after completion of the analysis.
Record the log entries in GMP Pro after completion of each activity during the analysis
Prepare and affix Approved, Rejected and Sampled as per the requirement.
Packing and Storage of reserve samples as per the procedure.
Sending of the samples for other laboratory testing (internal/external) as per the procedure.
Operate the wet lab instruments as per the respective instrument operating SOP's.
Check the validity of Chemicals, Reagents, Reference/Working Standards and calibration status of instruments prior to use.
Print the ARDS from GMP Pro and enter the test results after completion of the analysis.
Ensure the instrument log entries in GMP Pro after completion of each activity during the analysis.
Send the samples for other laboratory testing (internal/external) as per the procedure.
Maintenance and storage of all Chemicals, columns and Standards.
Stability/Hold time protocols/reports preparation, initiation and pullout of Stability samples as per the schedules.
Monthly Stability/Hold time schedules preparations, initiation and pullout of Stability/Hold time samples as per the schedules.
Calibrate the wet lab and HPLC instruments as per the pre-defined schedules.
Coordinates with vendors to perform PM and calibrations of stability chambers and monthly cleaning of chambers.
Discard the samples as per the disposal procedure upon satisfactory verification of batch release status.
Handover the solid, liquid waste and obsoleted columns to ETP for disposal as per the procedure.
To Co-ordinate with the supervisor in preparation of Investigation reports in the event of OOS, OOT and deviations.
Report all the departmental activities to the immediate supervisor and HOD.
Assisting the Head of the department for all QC related activities.
Attend for the scheduled and unscheduled OJT/GMP trainings.