Role & responsibilities

Key Responsibilities

- Perform and review Environmental Monitoring (EM) for sterile manufacturing areas (Grade A, B, C & D).
- Handle Bacterial Endotoxin Test (BET/BET) and Bioburden Limit Testing (BLT) activities.
- Perform Microbial Limit Testing (MLT) of raw materials, in-process samples, finished products, purified water (PW), WFI, and compressed gases.
- Review sterility testing, growth promotion tests, media preparation, and culture handling.
- Conduct environmental trend analysis and investigate out-of-limit/out-of-trend results.
- Handle microbial identification, deviations, OOS/OOT investigations, CAPA, and change control.
- Ensure compliance with USFDA, EU GMP, MHRA, WHO GMP, cGMP, and Data Integrity (ALCOA+) requirements.
- Prepare and review SOPs, protocols, reports, and laboratory documentation.
- Support regulatory inspections, customer audits, and internal quality audits.




- Mentor microbiology analysts and ensure compliance with laboratory safety and GMP practices.

Required Skills

- Environmental Monitoring (EM)
- Bacterial Endotoxin Test (BET)
- Bioburden Limit Testing (BLT)
- Microbial Limit Testing (MLT)
- Sterility Testing
- Water Testing (PW/WFI)
- Media Preparation & GPT
- Microbial Identification
- Trend Analysis
- OOS/OOT, Deviations, CAPA
- QMS & Data Integrity
- Regulatory Audit Readiness

Qualification

- M.Sc. Microbiology / Biotechnology / Life Sciences (preferred)
- B.Sc. Microbiology with relevant sterile injectable experience may also be considered.

Experience

- 814 years in Sterile Injectable Microbiology at a USFDA-regulated manufacturing facility, with experience in team handling and laboratory review activities.

Preferred candidate profile

📌 Assistant Manager Deputy Manager Microbiology Injectables (Hyderabad)
🏢 Aspiro Pharma
📍 Hyderabad