Role & responsibilities

- Perform routine analysis of pharmaceutical samples using HPLC/UPLC and other analytical instruments as per approved analytical methods.
- Carry out testing of raw materials, intermediates, API, in-process samples, finished products, cleaning samples, and stability samples.
- Prepare samples, mobile phases, diluents, standard solutions, and system suitability solutions accurately.
- Operate, maintain, and troubleshoot HPLC systems, including:

- HPLC instrument
- Autosampler
- Pump
- Column oven
- UV/PDA detector
- Chromatographic software

- Follow approved STP, SOP, specification, pharmacopoeial methods, and validated analytical procedures.
- Perform instrument calibration, qualification, and routine checks as applicable.
- Maintain HPLC columns properly, including column conditioning, storage, and performance monitoring.
- Perform basic troubleshooting of abnormal chromatograms, pressure fluctuations, peak splitting, ghost peaks, baseline noise, carryover, and other HPLC-related issues.
- Initiate and properly document investigations for OOS (Out of Specification), OOT (Out of Trend), atypical results, and analytical deviations as per site procedures.
- Maintain complete and accurate laboratory documentation, including worksheets, analytical reports, logbooks, and instrument records.
- Ensure compliance with GMP, GLP, data integrity, ALCOA+ principles,



and applicable regulatory requirements.
- Review analytical data and ensure that calculations and results are accurate and traceable.
- Support method validation, method verification, method transfer, and analytical method development activities where applicable.
- Participate in laboratory investigations, CAPA, change control, and continuous improvement activities.
- Ensure proper handling, labeling, storage, and disposal of chemicals, standards, samples, and laboratory waste.
- Maintain cleanliness and good housekeeping of the QC laboratory.
- Coordinate with Production, QA, R&D;/Analytical Development, and other departments when required.

Required Technical Skills

- Positive practical knowledge of HPLC operation and troubleshooting.
- Knowledge of chromatographic principles and HPLC method parameters.
- Understanding of assay and related-substances analysis.
- Knowledge of preparation and standardization of solutions.
- Ability to interpret chromatograms and investigate abnormal results.
- Knowledge of analytical instruments such as:

- HPLC/UPLC
- GC

Preferred candidate profile

Candidate should have hands-on experience in HPLC analysis of API/intermediate samples, strong understanding of chromatographic data, and practical knowledge of GMP documentation, system suitability, analytical calculations, and HPLC troubleshooting.

📌 QC - Officer/Sr. Officer (HPLC) (Vadodara)
🏢 Exemed
📍 Vadodara