HPLC Analyst – Job Responsibilities (Pharmaceutical Industry)
Position: HPLC Analyst
Department: Quality Control (QC)
Key Responsibilities
- Perform analysis of raw materials, in-process samples, finished products, stability samples, and cleaning validation samples using HPLC and other analytical instruments.
- Operate, calibrate, maintain, and troubleshoot HPLC systems from leading manufacturers such as Shimadzu Corporation
- Conduct assay, dissolution, related substances, impurity profiling, content uniformity, and method verification testing as per approved specifications.
- Prepare mobile phases, diluents, standard and sample solutions as per analytical procedures.
- Review chromatograms and ensure data integrity compliance (ALCOA+ principles).
- Maintain analytical records, laboratory notebooks, instrument logbooks, and test reports in compliance with cGMP and GLP requirements.
- Perform system suitability testing and ensure instruments are functioning within specified limits before analysis.
- Participate in OOS (Out of Specification), OOT (Out of Trend), deviation, and laboratory investigation activities.
- Support analytical method validation, verification, transfer, and stability studies.
- Coordinate with QA and Production departments for timely sample testing and release activities.
- Ensure adherence to SOPs, regulatory guidelines, and laboratory safety practices.
Qualification
- B.Sc./M.Sc. (Chemistry), B.Pharm, or M.Pharm.
- Experience in handling Waters, Agilent, Shimadzu, or Thermo HPLC systems in a pharmaceutical QC laboratory.
Key Skills
- HPLC/UPLC Operation & Troubleshooting
- Chromatographic Analysis
- Dissolution Testing
- Method Validation & Transfer
- cGMP / GLP Compliance
- Data Integrity (ALCOA+)
- OOS/OOT Investigation
- Documentation & Regulatory Compliance
Share resume at [Confidential Information] or WhatsApp at 8929700006
