Analyze various pharmaceutical materials including:
In-process samples
Intermediates
Raw materials
Packing materials
Finished products
Stability study samples
Hold time study samples
Process validation samples
Cleaning samples
Vendor development samples
Any other analysis allocated by the team leader.
Release analytical results with proper documentation.
Take responsibility for ensuring the quality and purity of pharmaceutical products using High-Performance Liquid Chromatography (HPLC) techniques.
Prepare samples for HPLC analysis according to established Standard Operating Procedures (SOPs) and specifications.
Analyze HPLC data, interpret results, and generate reports documenting test results and any deviations.
Ensure all analyses are performed in compliance with Good Laboratory Practices (GLP).
Ensure all raw analytical data is documented online.
Initiate, complete, and file daily analysis reports.
Ensure any abnormal results, incidents, deviations, or discrepancies are reported immediately to the reporting Section Head.
Ensure all relevant log entries are made for every activity wherever applicable.
Supervise compliance with all current Good Manufacturing Practices (cGMP), GxP, or any other regulatory requirements, including Environment, Health, and Safety (EHS) requirements.
Report any quality concerns or suggestions for improvements to the Department Head.
Execute and supervise all tasks and activities as per the applicable SOPs and company policy.
Maintain safety norms while working in the lab (e.g., wear goggles and Personal Protective Equipment (PPE), dispose of samples/media as per procedure, etc.).
Ensure analysis is performed according to valid procedures and by using calibrated instruments and standards.
Ensure self-discipline with respect to wearing aprons, attendance, personnel hygiene, and interpersonal relations.
Perform Labware Laboratory Information Management System (LIMS) related activities.
Handle any other assignments given by the Section Head or Department Head.

QC Executive

Job Description

Required Skills