Sr Officer

3 days ago

GUJARAT INDIA AHMEDABAD STAFF VIROCHAN NAGAR WEST Troikaa Group Full time ₹ 2,00,000 - ₹ 6,00,000 per year
  • 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 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
  • To carryout SAP related activities.

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