Qc Analyst

Job Description Quality Control (QC) Analyst

Experience: 1- 3 Years
Employment Type: Full-Time
Industry: Pharmaceutical Manufacturing

About the Role

We are seeking a skilled and detail-oriented Quality Control (QC) Analyst with hands-on experience in pharmaceutical analytical testing. The ideal candidate should have practical exposure to chromatographic techniques, spectroscopy, wet chemistry analysis, laboratory documentation, and regulatory compliance. The role involves testing of Raw Materials, In-Process samples, Finished Products, Packing Materials, and Stability samples while ensuring compliance with GMP, GLP, and Data Integrity guidelines.

Candidates should be willing to relocate.

Key Responsibilities

• Perform analytical testing of Raw Materials (RM), In-Process (IP), Packing Materials (PM), Finished Products (FP), and Stability Samples.
• Operate, calibrate, troubleshoot, and maintain laboratory analytical instruments.
• Perform routine analysis as per approved test methods, specifications, SOPs, STPs, and pharmacopoeial requirements.
• Prepare and standardize reagents, volumetric solutions, mobile phases, buffers, standards, and test solutions.
• Perform System Suitability Tests (SST) before sample analysis.
• Review chromatograms, spectra, and analytical results for accuracy and compliance.
• Execute wet chemistry analysis and physicochemical testing.
• Maintain laboratory documentation including analytical worksheets, instrument logbooks, calibration records, and test reports.
• Follow Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Data Integrity (ALCOA+) principles.
• Support investigations related to OOS (Out of Specification), OOT (Out of Trend), Deviations, and CAPA.
• Participate in method verification, method transfer, and stability studies as required.
• Ensure laboratory safety and compliance with regulatory requirements.

Required Technical Skills

Hands-on experience with any of the following analytical instruments:

• HPLC (High Performance Liquid Chromatography)
• UPLC (Ultra Performance Liquid Chromatography)
• GC (Gas Chromatography)
• UV-Visible Spectrophotometer
• FTIR / IR Spectroscopy
• Auto Titrator
• Karl Fischer Moisture Analyzer
• pH Meter
• Dissolution Tester
• AAS (Atomic Absorption Spectroscopy)
• ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
• Moisture Analyzer / LOD Equipment
• Analytical Balance

Material Testing Experience

Candidates should have experience in testing one or more of the following:

• Raw Materials (RM)
• In-Process Samples (IP)
• Packing Materials (PM)
• Finished Products (FP)
• Stability Samples
• Standards Preparation
• Reagent Preparation
• Wet Chemistry Analysis

Regulatory & Quality Knowledge

Working knowledge of:

• GMP (Good Manufacturing Practices)
• GLP (Good Laboratory Practices)
• GDP (Good Documentation Practices)
• Data Integrity (ALCOA+)
• SOPs & STPs
• OOS, OOT, Deviation, CAPA
• USP / IP / BP / EP Pharmacopoeias

Analytical Testing Experience

Experience in one or more of the following analyses:

• Assay
• Related Substances
• Identification Tests
• Dissolution Testing
• Loss on Drying (LOD)
• Moisture Analysis (Karl Fischer)
• pH Testing
• Residual Solvent Analysis
• Heavy Metal Analysis
• Elemental Impurity Analysis
• Content Uniformity
• Wet Chemical Analysis