Senior Officer, QC Testing

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 450,000 - 650,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a microbiology testing professional to perform in-process, utility, environmental, and finished product testing under GMP guidelines. You will evaluate results for accuracy, ensure compliance with standards, and escalate deviations as needed.

You will also handle environmental monitoring, media management, and method validation in a structured QMS environment. Ideal candidates hold a B.Sc.

Qualifications

• Bachelors in Science required; MSc preferred.
• Experience in GMP/ GLP laboratory environment is expected.
• Strong documentation and data integrity practices are essential.

Responsibilities

• Perform in-process, utility, environmental, and finished product microbiological testing per approved procedures.
• Review and interpret analytical results against specifications and acceptance criteria.
• Maintain records for environmental monitoring and utility testing in line with GMP and QMS requirements.
• Prepare, manage, and maintain microbiological media inventory and records; perform GPT on media.
• Execute analytical method validation, verification, and qualification activities as assigned; support investigations and CAPA.
• Ensure data integrity and compliance with regulatory expectations during all testing activities.

Skills

Microbiology Instrumentation Handling

GLP & Documentation

Data Integrity & Documentation

Regulatory Compliance

SOP Preparation & Revision

BET & Sterility testing

Interpretation of Resulting Data Trend

Laboratory Instrument qualification

Quality Control & Compliance

QMS Documentation

CAPA, Deviation, and Change Control

Education

B.Sc.

M.Sc - Preferred

Job description

Job Description

This role is responsible for performing in-process, utility, environmental, and finished product microbiological testing in compliance with approved procedures, Good Manufacturing Practices (GMP), and applicable regulatory requirements. The incumbent evaluates microbiological test results for accuracy, precision, and compliance with predefined specifications to ensure product quality, safety, and integrity. The position supports the identification of quality concerns through routine monitoring, investigation, and timely escalation of microbiological deviations. Activities are performed within a structured Quality Management System (QMS) aligned with 21 CFR Parts 210 & 211 and applicable Indian and international pharmaceutical regulations on Good Microbiology practices.

Job Description

This role is responsible for performing in-process, utility, environmental, and finished product microbiological testing in compliance with approved procedures, Good Manufacturing Practices (GMP), and applicable regulatory requirements. The incumbent evaluates microbiological test results for accuracy, precision, and compliance with predefined specifications to ensure product quality, safety, and integrity. The position supports the identification of quality concerns through routine monitoring, investigation, and timely escalation of microbiological deviations. Activities are performed within a structured Quality Management System (QMS) aligned with 21 CFR Parts 210 & 211 and applicable Indian and international pharmaceutical regulations on Good Microbiology practices.

Key Responsibilities

Microbiological Testing & Analysis

• Perform microbiological analyses including:
  
  
  
  • Bioburden Testing
  
  
  • Microbial Limit Test (MLT)
  
  
  • Sterility Testing
  
  
  • Bacterial Endotoxin Test (BET)
  
  
  • Water Analysis
  
  
  • Other routine microbiological evaluations as per approved procedures.
  
  
  
  


• Review and interpret analytical results against established specifications and acceptance criteria.


• Ensure all testing activities are executed and documented in accordance with current GMP, GDP, and laboratory procedures.
  

Environmental & Utility Monitoring

• Conduct environmental monitoring of microbiology laboratories, cleanrooms, and controlled manufacturing areas.


• Perform water sampling and microbiological analysis as per approved SOPs, protocols, and sampling plans.


• Maintain complete and accurate records related to environmental monitoring and utility testing.
  

Culture & Media Management

• Prepare, manage, and maintain microbiological media inventory and reconciliation records.


• Perform culture maintenance activities and ensure proper preservation of microbial cultures.


• Conduct Growth Promotion Testing (GPT) of microbiological media and document observations and results.
  

Method Validation & Laboratory Support

• Execute analytical method validation, verification, and qualification activities as assigned.


• Participate in laboratory investigations, troubleshooting, and technical assessments.


• Support laboratory compliance activities, audits, and inspections.
  

Quality Systems & Compliance

• Report and document Out of Specification (OOS), Out of Trend (OOT), and Environmental Monitoring (EM) excursions.


• Participate in investigations associated with deviations, incidents, laboratory discrepancies, and quality events.


• Support CAPA implementation, change control activities, and risk assessment processes.


• Ensure data integrity, documentation accuracy, and compliance with regulatory expectations.
  

Continuous Improvement

• Identify opportunities to improve laboratory efficiency, testing methodologies, documentation practices, and compliance systems.
  

Contribute to initiatives focused on quality enhancement and process optimization

Skills And Proficiency

• Microbiology Instrumentation Handling – Expert


• Good Laboratory Practices (GLP) & Documentation Accuracy – Practitioner


• Data Integrity & Documentation – Practitioner


• Regulatory Compliance – Practitioner


• SOP Preparation & Revision – Practitioner


• BET & Sterility testing expertise and evaluation skills – Expert


• Interpretation of Resulting Data Trend – Practitioner


• Laboratory Instrument qualification, Calibration & Maintenance – Practitioner


• Quality Control & Compliance – Practitioner


• QMS Documentation (OOS, OOT, Deviation & Incident) – Practitioner


• CAPA, Deviation, and Change Control Management – Practitioner

Education

QUALIFICATIONS

• B. Sc. - Required/ M.Sc - Preferred

Experience

• 2 years or more in 2 - 5 Years