Job Responsibilities:
GC :
- 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.
- Responsible to perform the GC analysis of Raw material, in-process/cleaning, intermediate, finished product and stability samples as per the work allotment.
- Check the Calibration, Preventive maintenance and status tag of the instruments prior to use.
- Operate and calibrate the instruments as per SOP.
- 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.
- Discard the samples as per the disposal procedure upon satisfactory verification of batch release status.
- Handover the solid and liquid waste to ETP for disposal as per the procedure.
- Check the validity of Chemicals, Reagents, Reference/Working Standards and instruments prior to use.
- 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.
HPLC :
- 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.
- Responsible to perform the HPLC analysis of Raw material, in-process/cleaning, intermediate, finished product and stability samples as per the work allotment.
- Check the Calibration, Preventive maintenance and status tag of the instruments prior to use.
- Operate and calibrate the instruments as per SOP.
- 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.
- Discard the samples as per the disposal procedure upon satisfactory verification of batch release status.
- Handover the solid and liquid waste to ETP for disposal as per the procedure.
- Check the validity of Chemicals, Reagents, Reference/Working Standards and instruments prior to use.
- 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 the scheduled and unscheduled OJT/GMP trainings.
Wet Lab :
- 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 the scheduled and unscheduled OJT/GMP trainings.
Instrumentation:
- 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.
- Check the Calibration, Preventive maintenance and status tag of the instruments prior to use.
- To perform the instrument calibration as per schedule.
- Print the ARDS from GMP Pro and record the data.
- Ensure the instrument log entries in GMP Pro after completion of each activity during the analysis.
- Send the Laboratory instruments for external calibration as per the procedure.
- Support the service engineer for external calibration/preventive maintenance.
- Update the instrument calibration/preventive maintenance status timely.
- Check the validity of Chemicals, Reagents, and Reference/Working Standards.
- Maintenance and storage of all Chemicals and Standards as per recommended Storage Conditions.
- Discard the chemicals/standards and handover to ETP for disposal as per the procedure.
- Report all the departmental activities to the immediate supervisor and HOD.
- Assisting the Head of the department for all QC related activities.
- Attend the scheduled and unscheduled OJT/GMP trainings. 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.
- Check the Calibration, Preventive maintenance and status tag of the instruments prior to use.
- To perform the instrument calibration as per schedule.
- Print the ARDS from GMP Pro and record the data.
- Ensure the instrument log entries in GMP Pro after completion of each activity during the analysis.
- Send the Laboratory instruments for external calibration as per the procedure.
- Support the service engineer for external calibration/preventive maintenance.
- Update the instrument calibration/preventive maintenance status timely.
- Check the validity of Chemicals, Reagents, and Reference/Working Standards.
- Maintenance and storage of all Chemicals and Standards as per recommended Storage Conditions.
- Discard the chemicals/standards and handover to ETP for disposal as per the procedure.
- Report all the departmental activities to the immediate supervisor and HOD.
- Assisting the Head of the department for all QC related activities.
- Attend the scheduled and unscheduled OJT/GMP trainings.
Key Competencies (Technical, Functional & Behavioral)
Technical & Functional:
- Good communication skills
- Demonstrate ownership and collaboration at work
Primary Responsibilities:
- Wear appropriate PPE and follow safety rules precisely.
