Assistant Manager / Manager Production (Sterile Injectables)

Immacule Life Sciences; Solan; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Immacule Life Sciences in Solan, Himachal Pradesh, is seeking a Production Lead to oversee sterile injectable manufacturing operations, including solution preparation, filtration, filling, sealing and lyophilization where applicable.

The role ensures aseptic processing, cleanroom compliance, data integrity, batch execution, and continuous improvement while coordinating with QA, Engineering and PPIC to maintain uninterrupted production.

Qualifications

Responsibilities

• Manage sterile injectable manufacturing operations, including solution preparation, filtration, filling, sealing, and lyophilization where applicable.
• Ensure aseptic processing practices, media fills (APS), contamination control strategies, and cleanroom requirements.
• Maintain cGMP compliance across Grade B, C, D, and CNC areas, as applicable.
• Ensure effective execution of equipment cleaning, component preparation, sterilization, and area clearance activities.
• Ensure accurate and timely completion of BMRs, SOPs, EDCS records, and other production documentation per data integrity requirements.
• Coordinate process validation, equipment qualification, calibration, preventive maintenance, and validated state maintenance.
• Support new product introduction, process optimization, scale-up, and technology transfer activities.
• Prepare and execute production plans; monitor batch progress, yield, productivity, equipment utilization, and production MIS.
• Coordinate material availability, consumables procurement, inventory control, and storage requirements with relevant departments.
• Monitor EMS/BMS trends and coordinate with QA and Engineering for timely resolution of environmental and facility-related issues.
• Manage production deviations, investigations, CAPAs, and change controls in coordination with QA and other stakeholders.
• Lead production personnel, ensure workforce discipline, and conduct cGMP, aseptic practices, and operational training.
• Ensure compliance with occupational health and safety requirements and promote zero-accident initiatives.
• Drive continuous improvement, cost optimization, waste reduction, and operational efficiency.
• Coordinate with QA, QC, Engineering, PPIC, Warehouse, Purchase, R&D, and Validation teams to ensure uninterrupted manufacturing operations.

Job description

Role & responsibilities

1. Manage sterile injectable manufacturing operations, including solution preparation, filtration, filling, sealing, and lyophilization, as applicable.
2. Ensure compliance with aseptic processing practices, media fills (APS), contamination control strategies, and cleanroom requirements.
3. Maintain cGMP compliance across Grade B, C, D, and CNC areas, as applicable.
4. Ensure effective execution of equipment cleaning, component preparation, sterilization, and area clearance activities.
5. Ensure accurate and timely completion of BMRs, SOPs, EDCS records, and other production documentation in accordance with data integrity requirements.
6. Coordinate process validation, equipment qualification, calibration, preventive maintenance, and validated state maintenance.
7. Support new product introduction, process optimization, scale-up, and technology transfer activities.
8. Prepare and execute production plans; monitor batch progress, yield, productivity, equipment utilization, and production MIS.
9. Coordinate material availability, consumables procurement, inventory control, and storage requirements with relevant departments.
10. Monitor EMS/BMS trends and coordinate with QA and Engineering for timely resolution of environmental and facility-related issues.
11. Manage production deviations, investigations, CAPAs, and change controls in coordination with QA and other stakeholders.
12. Lead production personnel, ensure workforce discipline, and conduct cGMP, aseptic practices, and operational training.
13. Ensure compliance with occupational health and safety requirements and promote zero-accident initiatives.
14. Drive continuous improvement, cost optimization, waste reduction, and operational efficiency.
15. Coordinate with QA, QC, Engineering, PPIC, Warehouse, Purchase, R&D, and Validation teams to ensure uninterrupted manufacturing operations.