- 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 Positive 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.