Description:
This role is responsible for conducting in-process and final product quality testing and analyses in strict compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates analytical results in terms of accuracy and precision against predefined specifications to ensure product integrity. Various measuring devices, testing equipment, and predetermined methods are employed to accept or reject products based on prescribed specifications. The role contributes to identifying ongoing quality issues and preventing potential production problems through proactive testing and timely escalation. Testing and reported in accordance with Good Manufacturing Practices. Random samples of finished goods are tested to verify conformance with internal and regulatory quality standards. The position supports continuous improvement initiatives by suggesting enhancements to testing methods and quality processes. It operates within a structured quality management framework aligned with 21 CFR Part 210 and 211, ICH guidelines, and applicable Indian and international pharmaceutical regulations.
Essential Functions:
- 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
