Officer/ Executive - QC

Job Summary

Quality Control Analyst

API (Oncology)

Key Responsibilities

• Perform analysis of raw materials, intermediates, finished products, in-process materials, packing materials, and stability samples
• Operate and maintain analytical instruments:
• HPLC (Shimadzu, Agilent, Empower, Chromeleon)
• GC, IR, UV, Moisture Balance, Karl Fischer (KF), Potentiometric Titration
• Conduct analytical investigations including:
• System Suitability Tests
• Laboratory Investigations
• OOS (Out of Specification), OOT (Out of Trend) analysis
• Root Cause Analysis and implementation of CAPA
• Ensure adherence to GMP, GLP, and applicable regulatory standards (FDA, WHO, ICH)
• Maintain accurate documentation and data integrity in compliance with audit and inspection requirements
• Collaborate with QA, ADL, R&D, and Production teams for process improvements
• Identify documentation gaps and suggest improvements to ensure compliance and efficiency
• Support internal and external audits through proactive documentation and team coordination
  

Key Skills & Competencies

• Strong analytical and documentation skills
• In-depth knowledge of cGMP/GLP and regulatory guidelines
• Proficiency in using analytical software (LabSolutions, Empower, Chromeleon)
• Detail-oriented with a passion for quality and data accuracy
• Excellent problem-solving and root cause analysis skills
• Team player with good communication and interpersonal abilities
  

Experience:

3 to 5 years in Quality Control

Educational Qualification : MSc / BSc in Chemistry / Analytical Chemistry

Industry: Pharma Bulk Drug /API/API oncology