Quality Control - Executive/Sr.Executive

Promea Therapeutics Pvt. Ltd.; Hyderabad; Vor Ort; INR 300.000 - 500.000; Vollzeit

Zusammenfassung

Promea Therapeutics Pvt. Ltd. in Hyderabad seeks a Quality Control - Executive/Sr.Executive to perform HPLC analysis on raw materials, in-process, stability and finished products.

The role ensures GLP compliance and accurate handling of instruments and reagents, supporting method validation and data release. You will prepare mobile phases and standards, calibrate HPLC systems, maintain stability chambers and actively participate in QMS, incident handling and deviation management as part of daily

Aufgaben

• Prepare STP, SOP and specifications as per approved methods.
• Perform HPLC analysis of raw materials, in-process, stability and finished product.
• Prepare mobile phases, reagents, standards and test solutions as per methods.
• Operate, calibrate and maintain HPLC systems daily.
• Ensure GLP compliance across activities.
• Handle operations and calibrations of instruments.
• Manage working standards, reference standards, primary standards and controls.
• Maintain stability chambers properly.
• Prepare method validation, verification, cleaning validation and stability study protocols and reports.
• Sample, test and release RM, PM, IP, FP, stability and water samples.
• Prepare reagents, indicators and volumetric solutions.
• Finalize review and release of analytical data.
• Monitor temperatures in laboratory and stability chambers daily.
• Handle QMS, incidents, ratifications and deviations.
• Initiate and close CCFs.

Jobbeschreibung

Quality Control - Executive/Sr.Executive

Job ID - 1064

Job Description:

• Responsible for preparation of STP,SOP & Specifications.
• Perform HPLC analysis of raw materials, in-process, stability, and finished product
• Prepare mobile phases, reagents, standards, and test solutions as per approved methods.
• Operate, calibrate, and perform routine maintenance of HPLC systems.
• Responsible for compliance for GLP practices.
• Responsible for handling of operations and calibrations of Instruments.
• Responsible for handling of working standards, Reference standards,Primary standards, and controls.
• Responsible for proper maintaince of stability chamber.
• Responsible for preparation of Method validation, Method verification,cleaning validation & Stability study protocols and reports.
• responsible for Sampling,testing and release of RM,PM,IP,FP, Stability & water samples.
• Responsible for preparation of reagents,Indicators & volumetric solutions.
• Responsible for final review & release of Analytical Data.
• Responsible for daily monitoring of temperatures in Laboratory and stability chambers.
• Responsible for handling of QMS.
• Responsible for handiling of Incidents,Ratifications & Deviations.
• Responsible for Initiation & Closing of CCF's.