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Senior Officer, QC Testing at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

06 Apr, 26

Salary

0.0

Posted On

06 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology Instrumentation Handling, Good Laboratory Practices, Data Integrity, Regulatory Compliance, SOP Preparation, BET Testing, Sterility Testing, Result Interpretation, Laboratory Instrument Qualification, Quality Control, QMS Documentation, CAPA Management, Deviation Management, Change Control Management

Industry

Pharmaceutical Manufacturing

Description

Maintain media stock and reconcile records of media used in analysis. Perform water sampling and analysis following defined SOPs/protocols and ensure proper documentation. Report and log OOS (Out of Specification), OOT (Out of Trend), and EM (Environmental Monitoring) excursions. Conduct environmental monitoring of the laboratory. Perform analytical validation, culture maintenance, and growth promotion testing (GPT) of media; record observations and generate reports. Carry out microbiology laboratory tests such as Bioburden Analysis, MLT (Microbial Limit Test), Sterility Testing, BET (Bacterial Endotoxin Test), etc., in compliance with approved procedures. 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) – Beginner CAPA, Deviation, and Change Control Management – Beginner

Responsibilities

The Senior Officer, QC Testing is responsible for maintaining media stock, performing water sampling and analysis, and conducting environmental monitoring in the laboratory. They will also carry out various microbiology laboratory tests and ensure compliance with approved procedures.