Manisha Dora

About Manisha Dora

Technically astute, Proactive, Performance-driven Pharmaceutical professional with more…

Experience

1. Senior Manager IT Qa

   Glenmark Pharmaceuticals

   Apr 2023 — Present · Mumbai, IN

   Leading the Corporate IT QA team of Six, handling Computer system validation of Enterprise Application, Quality Audits, QMS Documents, Process documents, Ensuring IT systems are Compliant with regulatory requirement, Training Management, Document lifecycle management. Performed Validation of computerized System as per V-Model (GAMP 5)- LabWare LIMS, SAP SuccessFactors, Oracle Argus, MSB Docs - Electronic Signature, eBMR, eCTD, OpenText Document Management System, TrackWise, LSRIMS, QR code implementation, CommVault, Shubham Smart tracker, UAM Portal, Zoho Vault. Performing Periodic review of computerized system, to evaluate validated state of the Computerized System Performing Vendor Audits to qualify the OEM Vendor/ Implementation partners. Quality Risk management (Risk Evaluation of the Computerized System, defining mitigation Plan, Risk communication) IT Document Lifecycle Management: Preparation and revision of SOP for managing the IT and quality systems and providing training for same and also review of Cross functional team SOPs. Review of existing Policies, Procedures and Work Instruction done with respect to the schedule defined. Conduct internal audit for the IT systems w.r.t defined procedures. Coordination with stakeholders and compliance with business processes. Gap Assessment and Remediation of Quality Systems. Initiation of QMS document in SAP system and ensuring that all the action items are closed within assigned TCD, performing CFT assessment, tracking of Open QMS for timely closure. Support in Regulatory (USFDA, TGA, WHO GMP, BfArM, ITGC) and Customer Audit

Education

• Principal K. M. Kundnani College of Pharmacy

  Bachelor of Pharmacy - BPharm

  2010 — 2013