Manoj Kumar Gandham Email and Phone Number

As a QMS specialist have around 14 years of experience in Pharmaceutical production department (Sterile Injectable section) with regulatory organizations like Mylan & Dr. Reddys laboratories Well handling of GMP/ QMS documentation as like Change management system, QRM (Quality Risk Management) preparation, Deviation and investigation process with root cause analysis, Implementation of CAPA, Qualification protocols preparation, Functional SOP preparation & review and BMR review.Having extensive cGMP & GDP knowledge in manufacturing of sterile dosage forms like Liquid vial/ Ampoule, Lyophilized products, PFS (Pre-filled syringes), Ophthalmic bottles, Terminal sterilized products, Isolator technology, Lyophilization.Have experience in green field project on injectable line and involved in the various equipments qualification activities like URS (User requirement Specification) preparation, Design qualification, FAT (Factory Acceptance Test)/ SAT (Site Acceptance Test), Installation qualification, Operational qualification and Performance qualification.• Handling of LMS system to track the functional personnel SOP training status.• Basic knowledge on CSV activities.Documentation tools handled in experience:• Track-wise system• Documentum• D2 Application• Fiori application for change controls• SAP (Documentation)• LMS (Learning Management System)