Inviting Applications for Quality control-Bidar

Sai Life Sciences Limited; India; On-site; INR 420,000 - 640,000; Full time

Job summary

Sai Life Sciences Limited is seeking a Quality Control professional for Bidar, Karnataka, India. The role involves GC and HPLC analyses across raw materials, in-process, and finished products, with emphasis on GMP compliance and accurate documentation.

The candidate will ensure instrument calibration, perform sample testing, and assist in investigations related to OOS/OOT, while adhering to safety and quality standards in a fast-paced laboratory environment.

Responsibilities

• Wear PPE and follow safety rules; follow cGMP/GLP and Good Documentation practices.
• Maintain good housekeeping in the laboratory and record Temperature and % Relative Humidity.
• Perform GC and HPLC analysis of raw materials, in-process/cleaning, intermediates, finished products and stability samples as per work allotment.
• Check calibration, preventive maintenance and status tags of instruments; operate and calibrate per SOP.
• Print ARDS from GMP Pro and log test results; ensure instrument logs are updated after each activity.
• Coordinate with supervisor for investigations in case of OOS, OOT and deviations; assist Head of Department in QC activities.
• Attend scheduled and unscheduled OJT/GMP trainings.

Job description

Inviting Applications for Quality control-Bidar Bidar, Bidar, Karnataka, India ..+ 1 4 - 8 Years Permanent

Job Description

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.
• 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.

Technical & Functional:

• Good communication skills
• Demonstrate ownership and collaboration at work

Primary Responsibilities:

• Wear appropriate PPE and follow safety rules precisely.