15 Sep
|
rudransh group
|
Roorkee
15 Sep
rudransh group
Roorkee
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
- Flexible 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