Monitoring of manufacturing related activity performed in Mfg facility.
To maintain proper planning, scheduling and achievement of production with optimum utilization of resources.
To preparation, review and implementation of all necessary standard operating procedure(SOP).
To preparation and review of batch manufacturing record and protocol.
Training given to all concern persons in their respective areas.
To arrange materials as per the plan.
To ensure completion of batch as per BMR and SOPs.
To investigation of product failure, system deviations.
To produce consistent positive quality output.
To investigate and analyze any quality issues during manufacturing through quality team.
To investigate deviation in yield through quality team and address issue.
To prepare MIS for reporting to reporting authority.
To ensure compliance to all regulatory and internal audits.
To coordinate with all departments i.e. with QC, QA, Engineering, HR and GDSO.
To coordinate with PTC team for smooth technology transfer.
To co-ordinate with PPMC, QC, and production department for Raw & Packing Material.
To inform department Head/plant head for any abnormalities i.e. deviations/events/safety events and for other day-to-day activities and to participate in investigation activities.
Responsible for QMS handling Initiation/Closure and closure related to Mfg./Pkg./Warehouse/Engineering.
To represent the external Audits and to participate in the internal self-Audits.
To ensure commercial supply is on time and as per expectation of planning function.
Equipment, Utilities and Area qualification for the Mfg Facility.
Preparation and execution of qualification protocols along with support team.
Compilation of the data and preparation of final qualification report.
Equipment re-qualification wherever and whenever required.
Ensuring PM/Calibration status of the Equipments /Instruments.