Role & responsibilities

The AGM / DGM Production is responsible for leading sterile injectable manufacturing operations to achieve production targets while ensuring compliance with cGMP, regulatory requirements, quality standards, safety, and cost objectives. The role requires extensive experience in managing multiple injectable manufacturing lines and driving operational excellence.

1. Lead end-to-end production operations for sterile injectable manufacturing.
2. Manage multiple manufacturing lines, including vial, ampoule, pre-filled syringe (PFS), liquid injectables, and lyophilized products.
3. Ensure timely execution of production plans and optimum utilization of manpower, equipment, and materials.
4. Drive productivity improvements by reducing downtime, batch failures, changeover time, and material wastage while improving OEE.
5. Lead and develop production teams, ensuring effective manpower planning and performance management.
6. Ensure compliance with cGMP and global regulatory requirements, including US FDA, EU GMP, WHO GMP, and MHRA guidelines.
7. Maintain production documentation and support regulatory inspections, customer audits, and internal audits.
8. Ensure compliance with aseptic manufacturing practices, contamination control,



environmental monitoring, media fills, and sterility assurance programs.
9. Coordinate with QA, QC, Engineering, Warehouse, Planning, Validation, and Supply Chain for smooth manufacturing operations.
10. Lead investigations related to deviations, batch failures, OOS/OOT (production-related), and implement effective CAPA.
11. Support equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, technology transfer, and current product introductions.
12. Ensure adherence to EHS policies and drive continuous improvement initiatives to enhance productivity, quality, and manufacturing efficiency

Preferred candidate profile

- Bachelor's degree in Pharmacy, Chemical Engineering. A Master's degree is preferred
- 1820 years of experience in pharmaceutical manufacturing, including significant experience in sterile injectable production.
- Proven experience managing multiple injectable manufacturing lines simultaneously.
- Experience with large-scale commercial manufacturing.
- Exposure to international regulatory inspections (US FDA, EU GMP, MHRA, WHO GMP).
- Experience in technology transfer and scale-up activities.

📌 AGM / DGM - Production (Sterile Injectables) (Telangana)
🏢 Anthea Pharma
📍 Telangana