2 - 5 years

3.0 - 4.0 Lacs P.A.

Tumkur

Posted:2 months ago| Platform: Naukri logo

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Skills Required

HPLCHplc AnalysisMethod ValidationAnalytical Method Development

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for a Quality Control (QC) Analyst with hands-on experience in HPLC (High-Performance Liquid Chromatography) . The candidate will be responsible for conducting analytical testing of raw materials, in-process samples, and finished products to ensure compliance with regulatory and quality standards. Key Responsibilities: Analytical Testing & Instrument Handling: Perform HPLC analysis of raw materials, intermediates, and finished products as per pharmacopoeia and in-house specifications . Operate, calibrate, and troubleshoot HPLC instruments (Agilent, Waters, Shimadzu, etc.). Conduct other analytical techniques such as UV Spectroscopy, Dissolution, FTIR, and GC (if required) . Maintain proper documentation (test reports, logbooks, and data sheets) as per GMP . Quality & Compliance: Ensure all activities comply with Good Laboratory Practices (GLP), GMP, and regulatory guidelines . Conduct method validation, verification, and transfer for HPLC analysis. Support OOS (Out of Specification) investigations, deviations, and CAPAs . Participate in internal and external audits (USFDA, WHO, MHRA, etc.). Process Improvement & Documentation: Prepare and review SOPs, analytical protocols, and reports . Maintain records in compliance with Data Integrity (ALCOA+ principles) . Work on troubleshooting and optimization of analytical methods for efficiency. Key Requirements: Education & Experience: B.Sc / M.Sc / B.Pharm / M.Pharm in Chemistry, Pharmaceuticals, or a related field. 2 to 6 years of hands-on experience in HPLC analysis within a pharmaceutical or analytical lab setting. Skills & Competencies: Expertise in HPLC operation, calibration, and troubleshooting . Strong understanding of ICH guidelines, USP/EP/JP pharmacopoeial methods . Experience in handling regulatory documentation and audits . Knowledge of other analytical instruments (GC, UV, FTIR, etc.) is a plus . Strong analytical and problem-solving skills. Roles

Pharmaceutical Manufacturing
Warwick Rhode Island

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