- Handling of overall IPQA activities
- LINE CLEARANCE & IN-PROCESS ACTIVITY:
- 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 current 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
- To carryout SAP related activities.
📌 Executive - IPQA - 3719 (India)
🏢 Troikaa Group
📍 India
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