QC - Officer/Sr. Officer (HPLC)

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

• Good 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.