Manager Senior Manager – Production (Injectables)
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Job Summary
Position: Manager / Senior Manager – Production
Experience: 12–16 Years
Function: Production / Manufacturing
Industry: Pharmaceutical – Injectable Manufacturing
Employment Type: Full-Time
Position Summary
We are looking for an experienced Production Manager / Senior Manager – Injectables with 12–16 years of hands-on experience in sterile injectable manufacturing.
The ideal candidate should have strong experience in manufacturing operations involving Vials Ampoules and Lyophilized (Lyo) products along with proven expertise in managing production teams ensuring GMP compliance improving productivity and delivering production targets while maintaining quality and safety standards.
The candidate should be capable of independently managing day-to-day injectable production operations and coordinating effectively with QA QC Engineering Warehouse Validation and other cross-functional teams.
Manage end-to-end production activities for sterile injectable products.
Plan execute and monitor production schedules in line with business requirements.
Ensure timely achievement of production targets while maintaining product quality.
Handle manufacturing operations for:
Vial filling
Ampoule filling
Lyophilized / Lyo products
Monitor batch manufacturing activities and ensure adherence to approved procedures and batch records.
Ensure effective utilization of manpower equipment materials and production resources.
Monitor production output yield rejection downtime and productivity.
Ensure strict adherence to aseptic processing and sterile manufacturing practices.
Monitor critical manufacturing parameters and environmental conditions.
Ensure compliance with cleanroom and controlled-area requirements.
Drive contamination-control practices across production operations.
Ensure proper gowning personnel hygiene and aseptic practices.
Work closely with QA to ensure compliance with sterile manufacturing requirements.
Manage manufacturing and filling operations for vial and ampoule products.
Monitor filling sealing inspection and associated manufacturing activities.
Ensure appropriate line clearance and equipment readiness before manufacturing.
Monitor filling-line performance rejection and yield.
Investigate and address recurring production issues.
Manage production activities involving lyophilized injectable products.
Coordinate with Engineering QA and Validation teams for lyophilizer operations.
Ensure adherence to approved lyophilization cycles and manufacturing procedures.
Monitor critical process parameters and cycle performance.
Support investigation of deviations process issues and cycle-related failures.
Drive improvements in lyophilization process efficiency and reliability.
Ensure all production activities comply with cGMP regulatory requirements and approved SOPs.
Maintain accurate and complete batch documentation.
Ensure timely completion of batch records and production documentation.
Support internal customer and regulatory audits.
Ensure timely closure of audit observations related to production.
Drive a strong culture of quality and compliance within the production team.
Participate in investigation of production deviations incidents OOS/OOT-related manufacturing issues and process failures.
Support root-cause analysis and implementation of appropriate CAPA.
Ensure effective and timely closure of deviations and corrective actions.
Identify recurring issues and implement preventive measures.
Lead and manage production officers executives supervisors and operators.
Allocate manpower across production activities and shifts.
Train and mentor production personnel on GMP SOPs and aseptic practices.
Conduct performance reviews and identify training requirements.
Build a culture of accountability discipline safety and continuous improvement.
Coordinate closely with:
QA
QC
Engineering
Maintenance
Validation
Warehouse
Supply Chain
Regulatory Affairs
Resolve production-related technical and operational issues.
Ensure smooth coordination between production and support functions.
Identify opportunities to improve production efficiency yield and equipment utilization.
Reduce rejection wastage downtime and production losses.
Drive continuous improvement and operational excellence initiatives.
Monitor production KPIs and prepare periodic performance reports.
Implement lean/manufacturing improvement initiatives wherever applicable.
Ensure adherence to plant safety procedures within production areas.
Identify potential operational and safety risks.
Ensure appropriate handling of materials equipment and manufacturing processes.
Promote a safe working environment across the production team.
Bachelor's degree in Pharmacy Pharmaceutical Sciences Chemical Engineering Biotechnology or a related discipline.
/ / MBA or relevant postgraduate qualification preferred.
12–16 years of relevant pharmaceutical production experience.
Strong experience in sterile injectable manufacturing is mandatory.
Candidates should have hands-on exposure to:
Injectables Sterile Manufacturing Aseptic Processing Vials Ampoules Lyophilized / Lyo Products Filling Operations GMP Batch Manufacturing Deviation CAPA Production Planning Team Management
Experience with USFDA / EU GMP / WHO GMP-regulated facilities.
Exposure to regulatory inspections and customer audits.
Experience in high-volume injectable manufacturing environments.
Experience in process optimization and productivity improvement.
Experience managing multiple production lines/shifts.
Sterile Injectable Production
Vial Manufacturing
Ampoule Manufacturing
Lyophilization / Lyo
Aseptic Processing
GMP Compliance
Production Planning
Batch Manufacturing
Deviation & CAPA
Root Cause Analysis
Team Leadership
Cross-functional Coordination
Productivity Improvement
Manufacturing Excellence
Problem Solving
Documentation & Compliance
The ideal candidate should be a hands-on injectable production leader with strong exposure to vials ampoules and lyophilized products.
Candidates who have primarily worked in oral solid dosage (tablets/capsules) API or formulation production without significant sterile injectable exposure should not be considered.
Please share profiles only if the candidate has:
12–16 years of pharmaceutical production experience
Strong sterile injectable manufacturing experience
Hands-on exposure to Vials
Hands-on exposure to Ampoules
Hands-on exposure to Lyophilized / Lyo products
Production team handling experience
Strong GMP / aseptic manufacturing knowledge
Experience with production documentation deviations and CAPA
Required Skills:
Sterile Injectable Production Vial Manufacturing Ampoule Manufacturing Lyophilization / Lyo Aseptic Processing GMP Compliance Production Planning Batch Manufacturing Deviation CAPA Root Cause Analysis Team Leadership Cross-functional Coordination Productivity Improvement Manufacturing Excellence Problem Solving Documentation & Compliance Injectables Sterile Manufacturing Vials Ampoules Lyophilized / Lyo Products Filling Operations Batch Manufacturing Production Planning GMP Deviation CAPA Team Management
