06 Aug
|
Gufic Biosciences
|
Indore
06 Aug
Gufic Biosciences
Indore
- Required Experienced grade B & C Officer for area & manpower handling
- Execute sterile injectable manufacturing activities as per approved Batch Manufacturing Records (BMR), Standard Operating Procedures (SOPs), production plans, and cGMP requirements.
- Operate, monitor, set up, clean, and perform basic troubleshooting of manufacturing equipment such as washing machines, autoclaves, dry heat sterilizers, filling & sealing machines, lyophilizers, inspection machines, and other production equipment.
- Perform all aseptic manufacturing activities by following approved aseptic techniques, gowning procedures, contamination control practices, and cleanroom behavior to maintain sterile conditions.
- Ensure accurate and timely completion of Batch Manufacturing Records (BMR), equipment logbooks, checklists, and other production records in accordance with Good Documentation Practices (GDP) and ALCOA+ Data Integrity principles.
- Maintain compliance with cGMP, Schedule M, WHO-GMP, EU GMP, US FDA guidelines, company SOPs, and all applicable regulatory and quality requirements.
- Perform and verify line clearance activities before and after batch execution, maintain housekeeping, ensure equipment cleanliness, and verify the status of equipment, materials, and production areas.
- Verify receipt of materials, perform material dispensing and reconciliation, and ensure proper handling, storage, traceability, and accountability of raw materials, packing materials, and finished products throughout manufacturing.
- Promptly report and participate in the investigation of deviations, incidents, non-conformances, change controls, risk assessments, and implementation of Corrective and Preventive Actions (CAPA).
- Coordinate with Engineering for preventive maintenance, calibration, qualification, and breakdown maintenance, ensuring equipment remains fit for intended use.
- Comply with all Environment, Health & Safety (EHS) requirements, use appropriate PPE, ensure protected handling of equipment and materials, and promote a safe working environment.
- Coordinate effectively with Quality Assurance, Quality Control, Warehouse, Engineering, Validation, and other cross-functional departments to ensure uninterrupted manufacturing operations.
- Attend and complete all assigned GMP, SOP, technical, EHS, and regulatory training programs, while providing on-the-job training and guidance to operators and junior staff whenever required.
- Support production planning, manpower allocation, shift coordination, supervision of operators and technicians, and achievement of daily production targets.
- Participate in continuous improvement initiatives including Lean, Kaizen, cost optimization, waste reduction, process improvements, and operational excellence programs to enhance productivity and quality.
- Ensure audit readiness of the production area at all times by supporting internal, customer, and regulatory inspections, addressing audit observations, and maintaining compliance with Quality Management System (QMS) requirements.
📌 Officer - Production (Indore)
🏢 Gufic Biosciences
📍 Indore