Description

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:

Qualifications

Education:

Experience:

Amneal

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