Quality Control Analyst

SENIOR QUALITY CONTROL ANALYST

Job Objective:

Qualifications:

Experience:

Job Responsibilities:

Method Development & Optimization:

• Develop and optimize analytical methods for assay, dissolution, related substances, and residual solvents using techniques like HPLC, GC, UV-Vis, FTIR.
• Establish and refine chromatographic conditions, mobile phases, and detection parameters for improved sensitivity and reproducibility.
• Conduct forced degradation and stability-indicating method development as per ICH Q1A guidelines.

Method Validation & Transfer:

• Perform method validation as per ICH guidelines covering accuracy, precision, specificity, linearity, robustness, and system suitability.
• Prepare and review method validation protocols and reports.
• Execute method transfer activities between R&D, QC, and manufacturing sites following GMP requirements.

Regulatory Compliance & Documentation:

• Ensure analytical methods meet US FDA, EU GMP, MHRA, WHO, and other regulatory expectations.
• Maintain accurate documentation as per Good Documentation Practices (GDP).
• Support regulatory filings by preparing analytical method validation reports and technical dossiers.
• Assist in responding to regulatory queries and audits related to analytical methods.

Instrumentation & Troubleshooting:

• Operate and maintain analytical instruments such as HPLC, GC, UV-Vis, FTIR, and dissolution testers.
• Troubleshoot chromatographic issues related to retention time shifts, peak tailing, and resolution problems.
• Participate in instrument qualification (IQ/OQ/PQ) as needed.

Collaboration & Process Improvement:

• Work closely with R&D, Manufacturing, and Quality Assurance teams for seamless method transfer.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results to identify root causes.
• Contribute to continuous improvements in analytical techniques and laboratory efficiency.

Technical Skills: