Production - AGM

Aspiro Pharma; Hyderabad; On-site; INR 2,800,000 - 4,200,000; Full time

Job summary

Aspiro Pharma Ltd. in Hyderabad seeks an experienced Production Leader to oversee sterile injectable manufacturing operations, ensuring on-time delivery while maintaining compliance with cGMP and global regulatory standards.

You will manage aseptic processing, vial and ampoule filling, lyophilization, packaging, and equipment utilization, driving improvements in yield, OEE, and cost. Strong leadership and cross-functional collaboration are essential.

Qualifications

• Educational qualification: B.Pharm/M.Pharm/M.Sc./B.Tech (Chemical/Biotechnology) or equivalent from a reputed institution.
• Strong knowledge of cGMP, GDP, Data Integrity and regulatory compliance requirements.
• Experience with regulatory inspections and customer audits.

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.

Skills

Sterile manufacturing

Leadership

Regulatory compliance

Process optimization

OEE tracking

Quality systems

Technology transfer

Education

B.Pharm/M.Pharm/M.Sc./B.Tech (Chemical/Biotechnology) or equivalent

Tools

ERP/SAP

Job description

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.
• Strong 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.