Role & responsibilities
- Perform analysis of Raw Materials, In-Process, Finished Products, Stability Samples, and Packaging Materials.
- Operate and troubleshoot analytical instruments such as HPLC, UPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, FTIR, and Karl Fischer.
- Conduct method verification, method transfer, and analytical method validation activities.
- Ensure compliance with cGMP, GLP, GDP, Data Integrity, and Regulatory Guidelines.
- Review analytical data, laboratory notebooks, and reports.
- Investigate OOS (Out of Specification), OOT (Out of Trend), deviations, and laboratory incidents.
- Preparation and review of SOPs, STPs, specifications, and analytical reports.
- Support regulatory audits including USFDA, MHRA, EU-GMP, WHO, TGA, and ANVISA inspections.
- Ensure calibration, maintenance, and qualification of laboratory instruments.
- Participate in stability studies and trend analysis activities.
Preferred candidate profile Hands-on experience in HPLC, UPLC, GC, Dissolution, UV-Visible Spectrophotometer, FTIR, Karl Fischer, and Wet Analys
📌 Quality Control (Solan)
🏢 Hetero
📍 Solan