Manager / Senior Manager - Production (Injectables) in Ahmedabad, भारत

Job Description – Manager / Senior Manager – Production (Injectables)

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.

Key Responsibilities

1. Injectable Production Operations

• 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.

2. Sterile / Aseptic Manufacturing

• 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.

3. Vial & Ampoule Manufacturing

• 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.

4. Lyophilization / Lyo Operations

• 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.

5. GMP & Regulatory Compliance

• 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.

6. Deviation, CAPA & Investigation

• 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.

7. Team Management

• 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.

8. Cross-Functional Coordination

• 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.

9. Productivity & Continuous Improvement

• 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.

10. Safety & Compliance

• 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.

Required Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related discipline .

• https://jobeax.com/link/g8jPrtYeTViWKuvF / https://jobeax.com/link/MPrGoo1PSJpZ7d0e / MBA or relevant postgraduate qualification preferred.

• 12–16 years of relevant pharmaceutical production experience .

• Strong experience in sterile injectable manufacturing is mandatory.

Mandatory Technical Experience

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

Preferred Experience

• 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.

Key Skills & Competencies

• 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

Ideal Candidate Profile

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 .

Recruiter Screening – Mandatory

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

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Job Requirements: 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