Line clearance in Injectable manufacturing, packing & warehouse dept.
To verified the documents of area cleaning, equipment cleaning and others.
Verification of temperature & relative humidity record and other logbooks of Injectable block.
In-Process quality control parameters check during various stages of manufacturing, filling & packing dept. Verification of Preventive Maintenance of Equipment's.
Handling & Review of Breakdown documents of equipment's.
Calibration & Verification of weighing balance.
Additional material verification of raw material & packing material.
Wash water and Swab sample collection at different stages of manufacturing and filling.
Verification of cleaned containers and utensils with respective logbook and checklist.
Sampling Activity:
Sampling of In-process samples, Bulk samples, Finished samples and Validation samples of Injectable area.
Sampling and Handling of Stability sample, Reference sample and Registration sample.
DOCUMENTATION:
Preparation of new SOPS and GMP documents, revision of SOPs and preparation of Training documents as and when required.
Initiation of Change control, Deviation and CAPA and assist Department In-charge in Failure investigation and Root cause analysis.
Handling & online filling of all GMP documents.
Review of the batch manufacturing & batch packing record at every stage of operation.
Verification of Material requisition slip and Dispensing slip at Manufacturing & Packing stage.
CROSS FUNCTIONAL ACTIVITY:
Verification & Execution of Process validation Study and Hold Time Study protocols.
Additional responsibilities given by Head of the department
