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. Manufacturing process deviations and defects in finished goods are identified, documented, 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.
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
