Officer, QC Environment Monitoring / MIcrobiology

Amneal Pharmaceuticals LLC; Bharuch District; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Bharuch district, Gujarat, seeks an experienced QC microbiology specialist to perform microbial testing of APIs, water, and environmental samples, ensuring accuracy and timely results.

You will maintain aseptic technique, operate LIMS, support investigations, audits, and data integrity, and ensure compliance with GLP, GDP and cGMP across all microbiological activities.

Qualifications

• Strong microbiology background required (API testing).
• Experience with GMP/GLP environment preferred.

Responsibilities

• Perform microbiological testing of APIs, purified water, and environmental samples.
• Conduct sampling and testing of water systems and air/surface/personnel in classified areas.
• Carry out microbial limit tests, sterility, endotoxin testing and other assays.
• Maintain accurate documentation of results in LIMS and lab records.
• Ensure aseptic technique and proper PPE usage; support investigations and data integrity.

Skills

Microbiological Testing

Instrument Handling

LIMS Operation

Documentation Review

GLP Compliance

Education

B.Pharm / M.Pharm

Tools

LIMS

Job description

Job 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

• Microbiological Testing (MLT, Sterility, Endotoxin) – Intermediate to Advanced
• Instrument Handling (Incubators, Autoclaves, Air Samplers) – Intermediate
• LIMS Operation and Data Entry – Intermediate
• Handling and Review of Microbiological Documentation – Intermediate
• Good Laboratory Practices (GLP) – Advanced

Qualifications

Education

• B.Pharm / M.Pharm – Acceptable with strong microbiology background

Experience

• 4 to 8 years of relevant experience in microbiological testing in an API

Job Info

• Job Identification 6583
• Job Category Quality Control
• Posting Date 08/03/2026, 06:08 AM