Executive- QC
Sai Life Sciences
2 - 6 years
Hyderabad
Posted: 18/06/2025
Job Description
Key Responsibilities:
• 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.
Key Competencies (Technical, Functional & Behavioral)
Technical & Functional:
• Good communication skills
• Demonstrate ownership and collaboration at work
About Company
Sai Life Sciences is a leading contract research, development, and manufacturing organization (CRO/CDMO) serving global pharmaceutical innovators by providing services across the drug discovery and development lifecycle.
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