Associate, Quality Control

Job Description

• To carry out the sampling of all the materials according to Standard Operating Procedure (SOP).
• To carry out the testing of Raw Material and Packing Material according to approved standard test procedure.
• To support Department Head in releasing of Raw Material and Packing Material
• To carry out the calibration of instruments as per the schedule.
• To coordinate with stability department for the working standards as per the guidelines and various pharmacopoeias.
• To ensure the status label on the material and transfer such material in the respective area.
• To prepare reagent & volumetric solution and standardize it.

• To carry out all the necessary tests as per respective specification and procedure and record the results for all the materials.
• To check the Stores and ensure the implementation of GMP norms in the stores.
• To inform to superior immediately in case of any Out of Specification result or Non-conformity or Laboratory Error Report observed or any instrument breakdown.

• To review the sampling activity of all the materials performed by team members.
• To assess the results of testing of Raw Material, Packing Material products to ensure alignment with standard operating procedure(SOP) and regulatory guidelines.
• To review results of the tests against the specification & Standard Test Procedure performed by team members.
• To ensure availability of the working & impurities standards as per various pharmacopoeias.
• To ensure the status label on the material and transfer such material in the respective area.
• To support Department Head, in investigation of out of specification (OOS), non-conformity and Laboratory Error Report (LER) and take corrective and preventive actions.
• To check and verify standardization and preparation of reagents and volumetric solution.
• To review periodic observation of retained sample done by team members
• To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC.
• To support & guide team members in implementing change control, Corrective and preventive actions (CAPA) and check effectiveness of CAPA, give suggestions form Divisional Head if required.
• To train team members on current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
• To assist Department Head in formation of SOP and give suggestions to improve system performance.
• To check, verify and review the calibration of all the analysis instruments whether performed as per the schedule.
• To ensure recording of all the data related to the testing online, on day-to-day basis and ensure traceability of the same.

,

• To carry out the sampling of all the materials according to Standard Operating Procedure (SOP).
• To carry out the testing of Raw Material and Packing Material according to approved standard test procedure.
• To support Department Head in releasing of Raw Material and Packing Material
• To carry out the calibration of instruments as per the schedule.
• To coordinate with stability department for the working standards as per the guidelines and various pharmacopoeias.
• To ensure the status label on the material and transfer such material in the respective area.
• To prepare reagent & volumetric solution and standardize it.

• To carry out all the necessary tests as per respective specification and procedure and record the results for all the materials.
• To check the Stores and ensure the implementation of GMP norms in the stores.
• To inform to superior immediately in case of any Out of Specification result or Non-conformity or Laboratory Error Report observed or any instrument breakdown.

• To review the sampling activity of all the materials performed by team members.
• To assess the results of testing of Raw Material, Packing Material products to ensure alignment with standard operating procedure(SOP) and regulatory guidelines.
• To review results of the tests against the specification & Standard Test Procedure performed by team members.
• To ensure availability of the working & impurities standards as per various pharmacopoeias.
• To ensure the status label on the material and transfer such material in the respective area.
• To support Department Head, in investigation of out of specification (OOS), non-conformity and Laboratory Error Report (LER) and take corrective and preventive actions.
• To check and verify standardization and preparation of reagents and volumetric solution.
• To review periodic observation of retained sample done by team members
• To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC.
• To support & guide team members in implementing change control, Corrective and preventive actions (CAPA) and check effectiveness of CAPA, give suggestions form Divisional Head if required.
• To train team members on current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
• To assist Department Head in formation of SOP and give suggestions to improve system performance.
• To check, verify and review the calibration of all the analysis instruments whether performed as per the schedule.
• To ensure recording of all the data related to the testing online, on day-to-day basis and ensure traceability of the same.

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Keyskills :
standard operating procedurecontinuous improvement facilitationchange controlmethod transferpacking materialpreventive actionsanalytical development