Job Description-
Perform detailed quality review of CMC documentation including specifications, batch records, validation documentation, stability protocols and reports, and technical reports- Review GMP documentation for compliance with FDA, EMA, ICH, and other applicable global regulatory requirements- Identify documentation gaps, inconsistencies, and compliance risks and recommend corrective actions- Support QC documentation review activities related to analytical methods, test records, and data packages- Provide QC documentation and quality review support for technology transfer activities, as needed- Support investigations related to QC deviations, OOS/OOT results, and documentation discrepancies- Support inspection readiness by ensuring CMC and GMP documentation is inspection-ready, accurate, and complete- Assist with responses to regulatory questions, inspection observations, and information requests related to CMC and QC topics- Review CMC and GMP documentation generated by CDMOs, testing laboratories, and other external partners- Provide clear, practical documentation feedback to vendors to drive compliance and quality improvements- Collaborate closely with CMC, QA, Regulatory Affairs, and external partners