Job Description for Production:
· Knowledge on GMP and Documentation
· Candidate from API Industry is preferred .Ability to handle Regulatory audits and able to work in shifts
· Knowledge on Unit Operations
Quality Control
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Operational Objectives :
§ Performing the analysis of all In process, Intermediates & recovery solvent samples.
§ Online issue of TI and ATR sheets of all in process, intermediate & recovery solvents to production after making sure that cross-checked sign by another analyst in shift and ensuring on-line compliance to shift documentation.
§ On line filling of all in process TI sheets and ATR sheets of recovery solvents and intermediate.
§ Preparation and standardization of volumetric solutions and test solutions related to in-process analysis as per schedule.
§ Online analysis and documentation immediately after completion of activity.
§ Maintenance of all required glassware for process lab.
§ Making sure disposal of all left over quantity of analysed samples on daily basis as and when analysis is completed.
§ Ensuring that shift-work is handed-over appropriately to reliever before leaving the lab.
§ Ensuring housekeeping of laboratory & cleanliness in place.
§ Ensuring daily performance of analytical instruments during the A-shift as per current ICM.
§ Reporting of on-line incidents, OOS, OOT as per prescribed format and SOP to QA and helping in investigating of root cause along with immediate supervisor.
§ Shall be undergone the functional training as well as other training.
§ Following of safety measures as per the given guidance.
§ Any other job given by HOD
§ Online monitoring of my SAP activities and release as and when completes the analysis.
§ Ensure compliance to all cGMP, cGXP or any other regulatory requirements.
§ Complete self-training.
§ Report any quality concerns or suggestions for improvements to managers.
§ Execute all tasks and activities as per the applicable SOPs.
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