Key Responsibilities
Sample Testing: Analyze raw materials, packaging materials, in-process samples, and finished pharmaceutical products.
Instrument Operation: Operate and calibrate lab equipment like HPLC, GC, UV-Vis Spectrophotometer, and dissolution apparatus.
Stability Studies: Conduct stability testing on designated batches under various environmental conditions.
Documentation: Maintain accurate test logs, raw data sheets, and Certificates of Analysis (CoA) following Valuable Laboratory Practices (GLP).
Compliance & Audits: Ensure daily lab operations adhere to cGMP, ICH, and internal Standard Operating Procedures (SOPs).
Investigations: Help troubleshoot out-of-specification (OOS) results and lab incidents.