Production (injectable) and QC (Microbiology)
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
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:
- / / / 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)
