Senior Officer, QC Method Validation & Transfer

This role is responsible for conducting analytical method validation and transfer activities in compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates method validation data in terms of accuracy, precision, specificity, and robustness against predefined acceptance criteria to ensure analytical method integrity. Various measuring devices, testing equipment, and predetermined validation protocols are employed to qualify analytical methods based on prescribed specifications. The role contributes to identifying ongoing method performance issues and preventing potential analytical failures through proactive validation monitoring and timely escalation. Method validation deviations and transfer failures are identified, documented, and reported in accordance with Good Manufacturing Practices. Validation samples are tested to verify conformance with internal and regulatory quality standards. The position supports continuous improvement initiatives by suggesting enhancements to method validation approaches and quality processes. It operates within a structured quality management framework aligned with ICH Q2 guidelines, 21 CFR Part 210 and 211, and applicable Indian and international pharmaceutical regulations.

• Perform analytical method validation and transfer activities in compliance with ICH Q2 guidelines and internal validation protocols

• Interpret and evaluate method validation data for accuracy, precision, specificity, and robustness against established acceptance criteria

• Operate measuring devices, testing equipment, and follow predetermined validation protocols to qualify analytical methods

• Test validation samples to verify conformance with method performance specifications

• Report method validation deviations, transfer failures, and defects to relevant stakeholders

• Identify ongoing method performance issues and recommend preventive measures to avoid potential analytical failures

• Maintain accurate and complete documentation of all method validation and transfer activities in accordance with GDP and GMP requirements

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

• 1 year or more in 1 - 4 Years