Pharma Analytical Validation Method

As a Validation Specialist at our company, your primary responsibility will be to plan, execute, and document analytical method validation activities for raw materials, in-process samples, finished products, and cleaning validation. This will involve assessing various parameters like accuracy, precision, specificity, linearity, robustness, LOD/LOQ, and others. You will also review and approve validation protocols and reports to ensure compliance with ICH Q2(R1), USP, and other regulatory standards, maintaining adherence to GMP, GLP, and cGMP guidelines. Your role will require collaboration with R&D, QA, and Production teams to facilitate seamless tech transfer and validation support. Troubleshooting analytical method issues, proposing enhancements, recommending revalidations, and performing maintenance and calibration of analytical instruments such as HPLC, GC, UV-Vis, and FTIR will be crucial aspects of your responsibilities. In preparation for regulatory inspections and internal audits, your participation will be essential. Additionally, you will be responsible for training and guiding junior QC staff on method validation procedures and regulatory expectations. Ensuring completeness, accuracy, and proper archiving of all documentation as per standard operating procedures (SOPs) will also be a key part of your role. This position is based in Giloth, Neemrana, Rajasthan, and requires prior experience in a similar role. The job is full-time and permanent, offering benefits including commuter assistance and provided meals, with a work schedule during day shifts and a yearly bonus component. On-site presence for work is necessary. If you possess the required experience in analytical method validation within a regulated environment, we encourage you to apply for this challenging opportunity.,