Job Description

Operate and troubleshoot HPLC systems (e.g., Waters, Agilent, Shimadzu) including autosamplers, columns, and detectors (UV/Vis, PDA).

- Prepare samples and standards: dilution, filtration, degassing, mobile phase preparation, buffer pH adjustment.

- Develop or follow validated analytical methods; set up sequences, integration parameters, and system suitability tests.

- Perform routine analyses for assay, related substances/impurities, dissolution, content uniformity, and stability studies.

- Ensure data integrity: accurate chromatogram integration, audit trails, and metadata handling in CDS (e.g., Empower, Open Lab).

- Maintain instruments: preventive maintenance, calibration checks, leak checks, pump seal replacement, lamp health monitoring.

- Document results in lab notebooks/eLIMS; generate CoAs; handle deviations, OOS/OOT, CAPA inputs.

- Follow GMP/GLP, ISO, and EHS practices; maintain cleanliness and 5S in the lab.

- Support method validation/verification and equipment qualification (URS, DQ/IQ/OQ/PQ) under supervision.

- Coordinate with QC/QA/Production teams for investigations and release activities.

Required Skills

- Strong understanding of chromatography principles, peak shape, resolution, tailing, carryover, and system suitability.

- Hands-on with column care and selection (C18, C8, HILIC, ion-exchange), guard columns, and column conditioning.

- Proficiency in chromatography data systems (Empower/OpenLab/Chromeleon): sequence creation, processing methods, reporting.

- Knowledge of regulatory guidelines: ICH Q2(R2) for validation, GMP/GLP data integrity (ALCOA+), stability ICH Q1.

- Basic statistics: %RSD, linearity, LOD/LOQ concepts; handling standard and sample preparations to minimize error.

Job Type: Full-time

Pay: ₹20,000.00 - ₹30,000.00 per month

Work Location: In person