About Company: Top 10 Pharma company having USFDA approved facilty for API Formulation and Biologics business.

Position: DGM - Sterile API Production(Dry Powder Injection)

Reporting To: Site Head
Department: Production
Location: USFDA-Regulated Pharmaceutical Manufacturing Facility

Job Purpose

To lead and manage sterile dry powder injectable manufacturing operations ensuring compliance with USFDA cGMP requirements product quality operational efficiency and timely achievement of production targets.

Key Responsibilities
Lead end-to-end production operations for sterile dry powder injectable products.
Ensure manufacturing activities comply with USFDA cGMP WHO-GMP and applicable regulatory requirements.
Ensure strict adherence to aseptic processing practices contamination control strategy (CCS) cleanroom discipline and environmental monitoring requirements.
Oversee batch manufacturing filling lyophilization (where applicable)



and associated production activities.
Ensure compliance with BMRs SOPs process validation and positive documentation practices.
Drive deviation investigations CAPA change controls and audit readiness in coordination with QA.
Ensure successful execution of media fills process validation and other applicable qualification activities.
Monitor production performance yields productivity equipment utilization and manufacturing costs.
Coordinate with QA QC Microbiology Engineering Warehouse and other cross-functional departments.
Lead train and develop production teams while building a solid quality and compliance culture.
Participate in USFDA inspections and ensure timely closure of production-related observations.
Drive continuous improvement operational excellence and EHS compliance.

📌 Dgm Sterile Api Production Hyderabad
🏢 Talental Consultings
📍 Hyderabad