4+ Year of experience in Pharmaceutical Industry Includes, 1. Preparation of DOSSIER for all pharmaceutical Products 2. NDA, ANDA filling, e-CTD 3. Sourcing of Pharmaceutical Product from India. 4. Review of Finished products and Stability reports. 5. Daily monitoring of lab activities and recording of QA observations. 6. Review of Analytical documents before submitting to IRA. 7. Review and Approving of Analyst/ Reviewer Qualification data. 8. Investigation of OOS and OOT in Quality Control and Stability Laboratories. 9. Review and Investigation of Laboratory Incidence, Deviation & Change control 10. Review of Protocol and Reports on Method Transfer and Method validation 11. Timely review the Audit trail of QC- Software Like Chromeleone, LIMS, Tiamo, Lab solution 12. Implementation of Corrective and Preventive Action (CAPA) in Quality Control Laboratory. 13. Handling of Regulatory queries related to Quality Control Laboratory 14. Sound knowledge Regarding ICH, US-FDA, MHRA Guidelines