Quality Control Analyst

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QC Analyst

Position Summary:

The QC Analyst will be responsible for conducting analytical testing of raw materials, in-process samples, and finished products with a primary focus on HPLC. The ideal candidate should be well-versed in regulatory standards and capable of working in a fast-paced, cGMP-compliant laboratory environment.

Key Responsibilities:

• Perform routine and non-routine analysis using HPLC for assay, dissolution, related substances, and stability studies
• Preparation, review, and maintenance of test data, analytical records, and reports in compliance with GMP and GLP
• Calibrate, operate, and troubleshoot HPLC and other analytical instruments (e.g., UV, FTIR, pH meter)
• Conduct testing of raw materials, intermediates, and finished formulations as per pharmacopeial and internal specifications
• Assist in method validation and transfer activities
• Investigate and document OOS/OOT results and deviations
• Ensure compliance with quality standards, SOPs, and regulatory requirements
• Maintain proper documentation and data integrity in line with audit expectations

Qualifications and Skills:

• B.Pharm / M.Pharm / M.Sc (Analytical Chemistry / Pharmaceutical Chemistry preferred)
• 2–5 years of experience in a pharmaceutical QC lab
• Strong hands-on experience in HPLC method execution and troubleshooting
• Familiarity with regulatory guidelines (e.g., ICH, cGMP, WHO, USFDA)
• Working knowledge of LabSolutions/Chromeleon / Empower or similar HPLC software
• Good documentation skills and attention to detail
• Ability to work independently as well as part of a team