Sterile Production Officer

Sun Pharma; Kamrup Metropolitan; On-site; INR 600,000 - 700,000; Full time

Job summary

Sun Pharma is seeking an experienced supervisor to oversee aseptic manufacturing activities, ensuring compliance with cGMP, regulatory requirements, quality standards, and safety procedures. The role focuses on timely execution of sterile operations while maintaining product quality and sterility assurance.

The incumbent will supervise operators, coordinate cross-functional teams, and ensure line clearance and deviations are managed with CAPA-driven actions.

Responsibilities

• Supervise daily aseptic manufacturing activities including formulation, filtration, filling, capping, and sterile processing operations.
• Ensure adherence to approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and GMP guidelines.
• Monitor production schedules and ensure timely completion of batches.
• Coordinate with Engineering, Quality Assurance, Quality Control, Warehouse, and Maintenance teams for smooth operations.
• Ensure proper line clearance before commencement and after completion of manufacturing activities.
• Maintain strict aseptic practices and contamination control measures within classified areas.
• Ensure personnel follow gowning procedures and aseptic behavior requirements.
• Monitor environmental conditions and coordinate corrective actions for deviations.
• Support media fill activities, aseptic process simulations, and process validations.
• Ensure compliance with regulatory requirements from USFDA, MHRA, EU-GMP, WHO-GMP, and other applicable agencies.
• Review and verify batch records, logbooks, equipment records, and production documentation.
• Investigate production deviations and assist in root cause analysis and CAPA implementation.
• Ensure timely closure of deviations, change controls, and quality events.
• Participate in audits and regulatory inspections.
• Maintain data integrity and documentation compliance throughout operations.
• Supervise and guide operators and technicians during shifts.
• Conduct training on GMP, safety practices, aseptic techniques, and SOPs.
• Monitor manpower deployment and shift allocation.
• Evaluate team performance and identify training needs.

Job description

To supervise and coordinate aseptic manufacturing activities in compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, quality standards, and safety procedures. The role ensures timely execution of sterile manufacturing operations while maintaining product quality, sterility assurance, and operational efficiency.

Key Responsibilities

Production Operations

• Supervise daily aseptic manufacturing activities including formulation, filtration, filling, capping, and sterile processing operations.
• Ensure adherence to approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and GMP guidelines.
• Monitor production schedules and ensure timely completion of batches.
• Coordinate with Engineering, Quality Assurance, Quality Control, Warehouse, and Maintenance teams for smooth operations.
• Ensure proper line clearance before commencement and after completion of manufacturing activities.

Aseptic Process Compliance

• Maintain strict aseptic practices and contamination control measures within classified areas.
• Ensure personnel follow gowning procedures and aseptic behavior requirements.
• Monitor environmental conditions and coordinate corrective actions for deviations.
• Support media fill activities, aseptic process simulations, and process validations.
• Ensure compliance with regulatory requirements from USFDA, MHRA, EU-GMP, WHO-GMP, and other applicable agencies.

Documentation & Quality

• Review and verify batch records, logbooks, equipment records, and production documentation.
• Investigate production deviations and assist in root cause analysis and CAPA implementation.
• Ensure timely closure of deviations, change controls, and quality events.
• Participate in audits and regulatory inspections.
• Maintain data integrity and documentation compliance throughout operations.

Team Management

• Supervise and guide operators and technicians during shifts.
• Conduct training on GMP, safety practices, aseptic techniques, and SOPs.
• Monitor manpower deployment and shift allocation.
• Evaluate team performance and identify training needs.