1. Under the defined US FDA Standard Facility URS, Preparing Project Feasibility Report depending on Capex, Opex and Sales Forecast.
2. Designing the Smart Pharma Factory Project Under the Umbrella of Pharma 4.0 considering eQMS, LIMS, MES, eDMS, eTMS, BEMS etc. ensuring the Data Integrity by Design and Green Factory by Design.
3. Ensuring Civil Readiness and availability of Capital Machines (Process and Utility) by concluding the technical superiority analysis among the vendors according to the User Required Specification (URS)
4. Ensuring the Readiness of Facility Including the Clean Room Design with Proper Air, Material and Personal Flow, Qualification by using Project Management Tools up-to product launching by organizing the every stakeholders for the completion of each task following the predecessors.
5. Making available of all RM and PM with prior source approval
6. Planning and Executing the Manufacturing of Engineering & Exhibit Batches for Submitting documents for ANDA.
7. Efficiently and Effectively Planning, Organizing, Monitoring, Controlling and Evaluating of Pharmaceutical dosage forms Production Operation Chanel focused on cGMP, Supply Chain and Economy of Scale.
8. Significant practical exposure in relevant guidelines like WHO, MHRA,EMEA, FDA, PDA, ISO EMS 14001:2004 and OHSAS 18001:2007, Bangladesh Labor Law.
9. Seasoned business operation and regulatory leader to deal with the regulatory bodies and MNCs (i.e. Novartis, GSK)
10. As QP Panel Member, conducted external and internal GMP audit. Conducted GMP audit at RM manufacturer site in China like Zhejiang Hisun, Tianjin Tinan, Shandong Keuyan and Shandong Fangming. Also conducted GMP audit at PM manufacturer site in Korea like SamaAluminium and Korea Aluminium.
11. Visited Romaco Killian Germany, Fedegari Italy, CMP Italy, Coster Italy, Dot. Bonapace Italy, Valmatic Srl Italy, Technomaco Italy, Jinagsu Gusu China, Hi-Fine China, Sejong Korea, Sky Softgel Korea, IWK Thailand, Augur Int'l Taiwan.