Manufacturing Operations
- Execute sterile manufacturing activities as per approved Batch Manufacturing Records (BMRs), SOPs, and production schedules.
- Perform operations related to:
- Component Preparation
- Washing and Sterilization
- Compounding
- Aseptic Filling and Sealing
- Lyophilization (Freeze Drying)
- Visual Inspection
- Secondary Packaging
- Operate and monitor manufacturing equipment to ensure smooth production activities.
- Ensure optimum machine utilization and productivity. Aseptic Processing & GMP Compliance
- Follow aseptic practices and cleanroom behavior requirements.
- Comply with gowning procedures and contamination control measures.
- Ensure adherence to cGMP, GDP, and Data Integrity requirements.
- Maintain cleanliness and housekeeping of manufacturing areas. Equipment Operation & Maintenance
- Operate equipment such as:
- Vial/Ampoule Washing Machines
- Sterilizers/Autoclaves
- Compounding Vessels
- Filling Machines
- Lyophilizers
- Capping Machines
- Visual Inspection Machines
- Perform routine equipment checks before and during operations.
- Coordinate with Engineering for breakdown maintenance and preventive maintenance activities.
- Participate in equipment qualification and validation activities. Documentation & Compliance
- Complete batch manufacturing records and logbooks accurately in real time.
- Ensure compliance with Valuable Documentation Practices (GDP).
- Maintain records related to production activities, equipment utilization, and cleaning operations.
- Review batch-related documents before submission. Investigation & Quality Systems
- Participate in deviation investigations, incident reporting, and root cause analysis.
- Support implementation of Corrective and Preventive Actions (CAPA).
- Assist in change control, qualification, and validation activities.
- Support internal audits, customer audits, and regulatory inspections. Coordination & Teamwork
- Coordinate with Quality Assurance, Quality Control, Engineering, Warehouse, and Planning departments.
- Support shift operations and production planning activities.
- Train operators and new team members on SOPs and GMP requirements.
- Contribute to continuous improvement initiatives and operational excellence programs. Safety & EHS Compliance
- Follow all Environmental, Health, and Safety (EHS) guidelines.
- Ensure safe handling of materials, chemicals, and equipment.
- Report unsafe conditions, incidents, and near misses promptly.
- Participate in safety trainings and emergency preparedness programs. Interested candidates can send resumes to
[email protected]
📌 Sterile Production Officer (Guwahati)
🏢 SUN PHARMA
📍 Guwahati