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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 10110849
- Position Id: 1535-10990-
- Posted 6 hours ago
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