Job Description

Key Responsibilities:


Perform routine microbiological testing of raw materials, in-process samples,

finished products, and water systems (e.g., TOC, endotoxin, bioburden, sterility).


Conduct environmental monitoring (viable and non-viable particle counts, surface

swabbing, personnel monitoring) in cleanrooms and controlled areas.


Perform validation activities including media fill simulations, cleaning validation, and

method validation.


Identify and investigate out-of-specification (OOS) and non-conformance issues in

collaboration with QA/QC.


Maintain accurate and complete microbiological records, logs, and documentation as

per cGMP.


Prepare microbial cultures, maintain microbial stock cultures, and carry out

identification of microorganisms.


Participate in internal and external audits and assist in CAPA implementation related

to microbiology.


Ensure laboratory instruments and equipment are calibrated, maintained, and

validated as per schedule.


Assist in the development and revision of SOPs, protocols, and microbiological

methods.


Support continuous improvement and training initiatives within the microbiology

lab.

Key Skills Required:


Attention to detail and strong documentation practices


Analytical and critical thinking


Familiarity with microbiology software systems (LIMS, etc.)


Ability to work independently and in teams


Good communication and reporting skills

Qualification:


B.Sc./M.Sc. in Microbiology, Biotechnology, or related field.


2-5 years of experience in a pharmaceutical microbiology lab, preferably sterile

manufacturing.


Good knowledge of current Good Manufacturing Practices (cGMP), GLP, and

regulatory guidelines (e.g., WHO, EU, USFDA).


Hands-on experience in microbial limit testing, sterility testing, and EM techniques.


Proficiency in data recording, documentation, and handling microbiology lab

equipment.

Job Type: Full-time

Pay: ₹30,000.00 - ₹40,000.00 per month

Schedule:

Day shift
Experience:

Microbiology: 2 years (Preferred) pharmaceutical microbiology lab: 1 year (Preferred) sterile manufacturing: 1 year (Preferred) microbial limit testing: 1 year (Preferred) sterility testing: 1 year (Preferred) EM techniques: 1 year (Preferred)
Work Location: In person