Inviting Applications for Quality control-Bidar

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.