Principal task and responsibilities: Support in Master Data Management and Training to employees. To perform the CSV related to computerized systems across the sites &its compliance. IT Compliance for computerized systems where user management and privileges is concern. To ensure the closure of change controls of computerized systems. Review of computerized systems regularly related to ensure compliance, policies and procedures. General documentation & Co-ordination for GMP IT compliance. Review of IT Controls of computerized systems. Review of user management logs and audit trail. Review of administrative activities. Ensure verification of backup and restoration on periodic basis. Review of backup logs. Ensure tagging of computerized systems as per SOP. Ensure inventory management of computerized systems as per SOP. System retirement review. Review of change control, new document initiation, Deviations, APQR, Out of specification, Out of trend, failure investigation, Return goods, Product recall documents. Preparation and Review of Risk Assessment for computerized GxP system. Review and approval of product related Risk Assessment. Review and Approval of Product Quality review. Approval of filled batch process record of Intermediates and Finished Drug Substance. Approving of Finished Drug Substance Certificate of Analysis. Document Control. Any work related to QA, as and when required
