Production (injectable) and QC (Microbiology)

We are seeking a highly skilled and detail-oriented professional to manage and execute operations in sterile injectable manufacturing. The role involves handling vial washing, depyrogenation, aseptic filling, autoclaving, lyophilization (lyo), compounding, and microbiological quality control activities within a regulated pharmaceutical environment. The candidate must ensure compliance with cGMP, regulatory standards, and aseptic practices.

Key Responsibilities

A. Production – Aseptic Area Operations

• Operate and monitor vial washing machines, depyrogenation tunnels, and ensure proper cleaning and sterilization cycles.
• Execute aseptic vial filling operations in classified cleanroom environments (Grade A/B/C/D).
• Handle autoclave operations including sterilization of equipment, components, and media using validated cycles.
• Manage lyophilization (freeze drying) processes including loading/unloading, cycle monitoring, and troubleshooting.
• Perform aseptic compounding activities as per batch manufacturing records (BMR).
• Ensure adherence to aseptic gowning procedures and cleanroom behavior protocols.
• Monitor environmental conditions (temperature, humidity, pressure differentials).

B. Equipment Handling & Validation

• Operate and maintain:
  • Vial washing machines
  • Sterilizers (Autoclaves)
  • Lyophilizers
  • Filling machines
• Support IQ/OQ/PQ validation activities for equipment.
• Perform routine calibration and preventive maintenance coordination.

C. Quality Control – Microbiology

• Perform microbiological testing including:
  • Environmental Monitoring (EM) – viable & non-viable
  • Water testing (PW, WFI)
  • Sterility testing
  • Bioburden analysis
  • Endotoxin testing (LAL)
• Conduct media preparation, growth promotion testing, and culture handling.
• Monitor cleanroom microbial trends and initiate corrective actions.
• Maintain documentation for all QC microbiology activities.

Required Qualifications

• Education:
  • B.Pharm / M.Pharm / B.Sc / M.Sc/ ITI/ Diploma
• Experience:
  • 2–7 years in sterile injectable manufacturing / QC microbiology

Required Skills

• Strong knowledge of aseptic techniques and sterile manufacturing
• Hands-on experience with vial filling, autoclaves, and lyophilizers
• Expertise in microbiological testing methods
• Familiarity with cleanroom classifications and behavior
• Good documentation and analytical skills
• Understanding of regulatory requirements (USFDA, EU GMP)

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