Senior Executive, QC Environment Monitoring

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

Job summary

Amneal Pharmaceuticals LLC is seeking a QC Microbiology professional in Ahmedabad, India. The role involves routine Environmental Monitoring and microbiological testing of raw materials and water systems in compliance with GMP. Candidates should have an M.Sc. in Microbiology or related fields and at least 7-10 years of relevant experience.

Key responsibilities include handling sterility testing, maintaining laboratory hygiene, and participating in regulatory audits. A candidate with experience in a sterile injectable manufacturing environment is preferred.

Qualifications

• Minimum 7–10 years of relevant experience in QC Microbiology.
• Experience in sterile injectable manufacturing environment is mandatory/preferred.

Responsibilities

• Perform routine Environmental Monitoring (EM) activities in cleanrooms.
• Conduct viable and non-viable monitoring.
• Perform microbiological testing of Raw Materials and Water Systems.
• Handle sterility testing activities in microbiology laboratory.
• Prepare and review EM and microbiology test records.
• Investigate EM excursions and microbiological testing deviations.
• Maintain laboratory hygiene and contamination control standards.
• Support media fill activities from a microbiological monitoring perspective.

Skills

Data Integrity & Documentation Security

Documentation & Record Control

Laboratory Safety

Microbial Monitoring

Quality Risk Analysis & Control

Regulatory Label Compliance Review

Surface and Personnel Monitoring

Trend Analysis for Environmental Data

Education

M.Sc. in Microbiology/Biotechnology/Life Sciences

Job description

Ahmedabad City, Gujarat, India

Job Description

Key Responsibilities

Perform routine Environmental Monitoring (EM) activities in classified cleanrooms (Grade A, B, C, D areas).

Conduct viable and non-viable monitoring including- Active air sampling, Surface monitoring (contact plates/swabs), Personnel monitoring, Settling plate exposure studies, Particle monitoring support

Perform microbiological testing of Raw Materials, Water Systems (PW/WFI), In-process samples, and Finished Products as per validated methods.

Handling sterility testing activities and ensure proper aseptic handling practices in microbiology laboratory.

Perform microbial limit tests, endotoxin testing support (where applicable), and bioburden testing.

Prepare and review EM and microbiology test records, worksheets, and logbooks in compliance with GMP.

Perform the investigation of EM excursions & Microbiology testing, OOS, OOT, and deviations, and support root cause analysis.

Ensure proper incubation, observation, and interpretation of microbiological test samples.

Maintain microbiology laboratory hygiene, aseptic practices, and contamination control standards.

Ensure calibration, cleaning, and maintenance of microbiology instruments and EM equipment.

Involve in change control review and approval, Deviation, Investigation and root cause investigation. Involve in SOP Review and its implementation and Training.

Support media fill (APS) activities from microbiological monitoring perspective.

Maintain compliance with ALCOA+ data integrity principles in manual and electronic documentation systems.

Ensure timely completion of testing activities to support production and product release timelines.

Assist in preparation and revision of SOPs, protocols, and microbiology-related documentation.

Coordinate with QA, Production, Validation, and Engineering teams for microbiological compliance activities.

Participate in regulatory and customer audits by providing required microbiological data and records.

Support implementation of contamination control practices in sterile manufacturing areas.

Qualifications

M.Sc. (Microbiology / Biotechnology / Life Sciences) or equivalent qualification with Minimum 7–10 years of relevant experience in QC Microbiology.

Experience in sterile injectable manufacturing environment is mandatory/ preferred

Required Skills

• Data Integrity & Documentation Security
• Documentation & Record Control
• Laboratory Safety
• Microbial Monitoring
• Quality Risk Analysis & Control
• Regulatory Label Compliance Review
• Surface and Personnel Monitoring
• Trend Analysis for Environmental Data

Job Info

• Job Identification 8252
• Job Category Quality Control
• Posting Date 06/27/2026, 05:13 AM
• Locations Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat, 380015, IN