Role & responsibilities

- Lead and manage complete sterile injectable manufacturing operations to achieve production targets.

- Ensure compliance with cGMP, regulatory guidelines, and company quality standards.

- Oversee aseptic processing, vial filling, ampoule filling, lyophilization, and packaging activities.

- Plan and execute daily, weekly, and monthly production schedules.

- Optimize manpower, equipment, and material utilization to improve productivity.

- Monitor batch manufacturing activities and ensure right-first-time execution.

- Review and approve BMRs, SOPs, deviations, CAPAs, and change controls.

- Maintain audit readiness for USFDA, EU GMP, MHRA, WHO, and other regulatory inspections.

- Drive continuous improvement initiatives to enhance yield, efficiency, and cost effectiveness.

- Coordinate with QA, QC, Engineering, Warehouse, and Supply Chain departments.

- Support qualification, validation, and technology transfer activities for new products.

- Ensure timely investigation and closure of production deviations and incidents.

- Implement and monitor EHS programs to maintain a safe working environment.

- Lead, mentor, and develop production teams through training and performance management.

- Track production KPIs such as OEE, productivity, batch release timelines, compliance, and operational excellence.

Preferred candidate profile

- 15-20+ years of experience in pharmaceutical manufacturing,



preferably in sterile injectable facilities.

- Minimum 5 years in a leadership role such as Production Manager, Senior Manager, or AGM Production.

- Strong exposure to aseptic manufacturing operations including Vial, Ampoule, PFS, and Lyophilized products.

- Experience working in USFDA, EU GMP, MHRA, WHO, ANVISA, or TGA approved plants.

- Thorough knowledge of cGMP, GDP, Data Integrity, and regulatory compliance requirements.

- Proven track record of handling regulatory inspections and customer audits.

- Expertise in managing high-volume sterile injectable production lines.

- Strong experience in deviation investigations, CAPA management, change controls, and risk assessments.

- Hands-on exposure to technology transfer, process validation, qualification, and scale-up activities.

- Ability to drive productivity improvement, yield enhancement, and cost optimization initiatives.

- Experience in leading and developing large cross-functional production teams.

- Robust knowledge of isolators, RABS, cleanroom operations, and contamination control strategies.

- Familiarity with ERP/SAP systems, production planning, and inventory management.

- Excellent leadership, decision-making, problem-solving, and stakeholder management skills.

- Educational qualification: B.Pharm/M.Pharm/M.Sc./B.Tech (Chemical/Biotechnology) or equivalent from a reputed institution.

📌 Production - AGM (Hyderabad)
🏢 Aspiro Pharma
📍 Hyderabad