Good knowledge about cGMP, ALCOA+ and all QMS tools like Change control, Deviation. Also proficient in handling of software like SAP, eTMS, eDMS, trackwise etc. Review MBMR & MBPR and it's relevant documents. Well handled training management system and Regulatory affairs related works. Having detailed experience in Preparation and review of APQR. Also having experience in preparation & review of Genuineness verification. In previous company,having experience in Qualification & validation, IPQA & Also working in Change control activity. In Qualification Section Like Equipment, Utility, AHU etc.