HPLC Analyst

Unison Pharmaceuticals; Ahmedabad District; On-site; INR 350,000 - 550,000; Full time

Job summary

Unison Pharmaceuticals is seeking a QC analyst responsible for performing HPLC analyses on raw materials, in-process and finished products, plus stability samples. You will prepare samples and standards, operate and troubleshoot HPLC equipment, and review chromatograms to ensure data integrity.

You will adhere to cGMP/GLP, SOPs and participate in method validation, transfer, and CAPA activities, while maintaining logs, records, and timely reporting to QA and production teams.

Qualifications

• HPLC analysis of Raw Materials, In-process, Finished Products and Stability Samples.
• Prepare samples, standards, reagents and mobile phases per approved methods.
• Operate, maintain and troubleshoot HPLC instruments.
• Perform system suitability and review chromatograms and analytical results.
• Maintain instrument logbooks, analytical records and QC documentation.
• Follow cGMP, GLP, SOPs and data-integrity requirements.
• Support OOS/OOT investigations, deviations and CAPA.
• Assist in method validation, verification and transfer activities.
• Ensure analysis is completed within required timelines.
• Coordinate with QA, Production and other departments.
• Maintain housekeeping and safety in QC laboratory.

Responsibilities

• Perform HPLC analysis of raw materials, in-process, finished products and stability samples.
• Prepare samples, standards, reagents and mobile phases as per approved methods.
• Operate, maintain and troubleshoot HPLC instruments.
• Perform system suitability and review chromatograms and analytical results.
• Maintain instrument logbooks and QC documentation.
• Follow cGMP, GLP, SOPs and data integrity requirements.
• Support OOS/OOT investigations, deviations and CAPA.
• Assist in method validation, verification and transfer activities.
• Ensure analysis is completed within required timelines.
• Coordinate with QA, Production and other departments as needed.
• Maintain proper housekeeping and safety practices in the QC laboratory.

Skills

HPLC analysis

Sample preparation

Chromatogram review

Documentation & records

cGMP/GLP compliance

CAPA investigations

Method transfer/validation

Lab safety

Tools

HPLC Instruments

Job description

Role & responsibilities

• Perform HPLC analysis of Raw Materials, In-process, Finished Products and Stability Samples.
• Prepare samples, standards, reagents and mobile phases as per approved methods.
• Operate, maintain and troubleshoot HPLC instruments.
• Perform system suitability and review chromatograms and analytical results.
• Maintain instrument logbooks, analytical records and other QC documentation.
• Follow cGMP, GLP, SOPs and data-integrity requirements.
• Support OOS/OOT investigations, deviations and CAPA.
• Assist in method validation, method verification and method transfer activities.
• Ensure analysis is completed within the required timelines.
• Coordinate with QA, Production and other departments whenever required.
• Maintain proper housekeeping and safety practices in the QC laboratory.