Experience in Lab QA/ QC. Experience in Commercialization Operational QA, Tech Transfer & ADL Check for the adequacy of the investigations & coordinate with the CMO,internal stake holders to get the complete/ complaint investigation through QRM's. Sterile preferred. Desired Candidate Profile - Knowledge and working experience with USFDA / EU. Knowledge on handling of Investigations/Deviations. Act as investigator in Trackwise system & route it to the Operational Quality Lead / respective QRM's for approval and disposition.