Senior Officer, QC Testing
Amneal Pharmaceuticals
Date: 3 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
Educational qualification: B.Sc./ M.Sc. (Microbiology)
Experience: 1 to 3 Years.
Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.
- Maintain media stock and reconcile records of media used in analysis.
- Perform routine GLP activity.
- 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.
- Microbiology Instrumentation Handling – Expert
- Good Laboratory Practices (GLP) & Documentation Accuracy – Practitioner
- Data Integrity & Documentation – Practitioner
- Regulatory Compliance – Practitioner
- SOP Preparation & Revision – Practitioner
- MLT, 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
Educational qualification: B.Sc./ M.Sc. (Microbiology)
Experience: 1 to 3 Years.
Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.
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