Senior Officer QC Testing

Amneal Pharmaceuticals LLC; Sanand; Vor Ort; INR 400.000 - 600.000; Vollzeit

Zusammenfassung

Amneal Pharmaceuticals LLC in Gujarat's Sanand region is seeking a Microbiology Laboratory Analyst to perform in-process and finished product microbiological testing in compliance with GMP and regulatory requirements. You will review results, support environmental monitoring, culture maintenance, method validation, and investigations, ensuring data integrity and quality systems are followed.

Candidates should have 2+ years in microbiology, B.Sc.

Qualifikationen

• BSc required; MSc preferred.
• Minimum 2 years in microbiology/QA or lab roles.

Aufgaben

• Perform microbiological analyses including Bioburden, MLT, Sterility, BET, Water Analysis.
• Review and interpret analytical results against specifications.
• Ensure testing activities follow GMP, GDP and lab procedures.
• Environmental monitoring of labs, cleanrooms and controlled areas.
• Culture maintenance and GPT of media; inventory management.
• Execute method validation, verification and qualification activities.
• Support investigations, audits and CAPA within the QMS.

Kenntnisse

Microbiology Instrumentation

GLP Documentation

Data Integrity

Regulatory Compliance

SOP Preparation

BET & Sterility Testing

Data Trend Interpretation

Instrument Maintenance

Quality Control

QMS Documentation

CAPA & Change Control

Ausbildung

B.Sc.

M.Sc (Preferred)

Tools

Laboratory Instruments

Jobbeschreibung

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

Qualifications

Education:

• B. Sc. - Required/ M.Sc - Preferred

Experience:

• 2 years or more in 2 - 5 Years