JOB RESPONSIBILITIES • Issuance of documents (SOP formats, logbook, register and LNB etc.) to cross-functional departments based on request. • Review of process development report/ Addendum to PDR/ Investigation report. • Review and approval of Analytical Method Validation protocol and report. • Review vendor qualification documents, vendor qualification report and performed vendor audit as and when required. • Review and approval of Specification and STP. • Handling of QMS like change control, incident and CAPA. • Receiving of outside sample and distribution to concerned department. • Co-ordinate with R&D, ADL, PERL, RA & Plant QA for PDR and analytical related activities. • Monitoring of GLP activity in analytical laboratory and R&D lab. • Handling of internal audit. • Routine lab monitoring in ADL, Synthesis lab & PERL. • Tracking of SOP effectiveness and review requirements. • Handling of SOP management system. • Review and approval of outside sample testing and analytical test report. • Other work allocated by DQA head as per requirement.
