Core Testing & Analysis
- Sample Testing: Analyze raw materials, in-process mixtures, final small-volume injections, and stability study samples.
- Solution Preparation: Make mobile phases, standard references, blanks, and test samples accurately.
- Method Execution: Follow pharmacopeial guidelines like IP, USP, or BP alongside exact in-house protocols.
Instrument Operation & Care
- Daily Operation: Run, monitor, and shut down HPLC systems for assays and impurity tests.
- Calibration & Tuning: Perform system suitability tests, routine calibrations, and performance checks before testing.
- Troubleshooting: Fix common HPLC issues like baseline noise, pressure spikes, leaks, or pump errors.
Compliance & Data Integrity
- Documentation: Record all calculations, weight logs, and sequence runs following Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
- Data Security: Ensure electronic data and audit trails comply with 21 CFR Part 11 and ALCOA+ principles.
- Deviation Management: Report and document Out of Specification (OOS) or Out of Trend (OOT) results immediately.
Audit & Team Support
- Cross-Functional Work: Share timely batch release data with the Production and Quality Assurance (QA) teams.
- Audit Readiness: Help manage documentation and answer questions during internal reviews and external regulatory inspections (USFDA, WHO, MHRA).
Pay: ₹30,000.00 - ₹45,000.00 per month
Benefits:
- Flexible schedule
- Food provided
- Health insurance
- Leave encashment
- Life insurance
- Paid sick time
Education:
Experience:
- Qc Hplc: 4 years (Required)
Work Location: In person
