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