Quality Control Analyst

SENIOR QUALITY CONTROL ANALYST

Job Objective: The Quality Control (QC) Analyst specializing in Method Validation and Method Development is responsible for developing, validating, and transferring analytical methods for pharmaceutical raw materials, intermediates, and finished products. The role ensures compliance with regulatory requirements and contributes to continuous improvements in analytical methodologies.

Qualifications: Bachelors/Masters degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or related field.

Experience: More than 8 years of experience in method validation, method transfer, and regulatory compliance within a pharmaceutical QC or analytical development environment.

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: Strong expertise in HPLC, GC, UV-Vis, FTIR