HPLC Analysis: Perform routine, in-process, and stability testing of API batches using HPLC systems and software like Empower.Method Execution: Handle Analytical Method Validation (AMV), method transfer, and verification protocols as per ICH and USP guidelines.Instrument Management: Calibrate, operate, and troubleshoot HPLC instruments and related laboratory equipment

Investigations: Lead investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviations.CAPA Implementation: Propose and close Corrective and Preventive Actions (CAPA) to prevent reoccurrence.Data Integrity: Maintain compliance with cGMP, GLP, and ALCOA+ data integrity

Record Review: Prepare and review Certificates of Analysis (COA), Standard Operating Procedures (SOPs), and Standard Testing Procedures (STPs).Audit Readiness: Face and support internal audits as well as regulatory inspections

Pay: ₹40,000.00 - ₹50,000.00 per month

Advantages
Versatile schedule
Life insurance
Paid sick time
Provident Fund

Education:
Bachelor's (Preferred)

Experience:
Hplc: 7 years (Required)

Work Location: In person

📌 Sr Hplc Executive Api Plant Exprince Roorkee
🏢 rudransh group
📍 Roorkee