Analytical Method Development Specialist x2

No detailed description provided.

• Design and execute development and validation of analytical methods including HPLC, UV-Vis, FTIR, GC and dissolution techniques. • Prepare and execute method development and validation protocols and reports in compliance with ICH guidelines. • Optimize analytical parameters to ensure method accuracy, precision, specificity, linearity, robustness and system suitability. • Conduct forced degradation studies and stability-indicating method development for regulatory filing. • Troubleshoot analytical challenges and refine existing methods to improve performance and efficiency. • Coordinate with QC and QA teams to facilitate method transfer and training for routine use. • Maintain accurate records and raw data in compliance with ALCOA+ data integrity principles. • Support CTD Module 3 (P.5 and S.4) preparation for product registration. • Ensure analytical instrumentation is properly qualified, calibrated, and maintained. • Contribute to audit readiness, regulatory inspections, and continuous improvement initiatives. • Minimum of 4–6 years of experience in analytical method development within a pharmaceutical R&D or QC environment. • Proficiency in analytical instruments such as HPLC, UV, FTIR, GC and dissolution testers. • Strong understanding of ICH Q2(R2), USP/BP/Ph. Eur. compendial methods, and validation life cycle. • Hands-on experience in handling stability studies and impurity profiling. • Familiarity with Good Laboratory Practices (GLP), GMP documentation, and regulatory submission requirements.