Essential Functions

* Perform microbiological testing of APIs, purified water, and environmental
samples as per approved specifications and methods.
* Conduct sampling and testing of water systems (PW) and environmental
monitoring (air, surface, personnel) in classified areas.
* Carry out microbial limit tests (MLT), sterility testing, endotoxin testing,
and other microbiological assays.
* Ensure accurate and timely documentation of test results in LIMS and
laboratory records.
* Maintain and calibrate microbiological instruments (e.g., incubators,
autoclaves, particle counters, air samplers) as per SOPs.
* Participate in investigations related to microbial contamination, OOS,
deviations, and incidents.
* Ensure compliance with GLP, GDP, and cGMP in all microbiological activities.
* Maintain aseptic techniques and laboratory hygiene, including proper use of
PPE and biosafety protocols.
* Support review and archival of microbiological data and records as per data
integrity norms.
* Carry out any other assignments allocated by the QC Head or Designee.

Additional Responsibilities





* Assist in method validation, verification, and transfer of microbiological
methods.
* Support preparation and revision of SOPs, specifications, and microbiological
methods.
* Participate in internal and external audits, providing relevant
microbiological data and documentation.
* Ensure proper retention, reconciliation, and disposal of microbiological
samples and cultures.
* Support trending and analysis of microbiological data (e.g., EM trends, water
system trends).
* Coordinate with production and QA teams to ensure timely microbiological
clearance and batch release.
* Report any equipment malfunctions or microbiological concerns to the
supervisor promptly.

Skills:

* Microbiological Testing (MLT, Sterility, Endotoxin) – Intermediate to
Advanced
* Environmental Monitoring & Water Testing – Intermediate
* Instrument Handling (Incubators, Autoclaves, Air Samplers) – Intermediate
* LIMS Op

📌 Officer, QC Environment Monitoring (India)
🏢 Amneal
📍 India