SUMMARY Acting Site Head Quality for XELLIA Pharmaceuticals - Facility was under Consent Decree-FDA Director Global Quality Ops-Tech Services Injectable Vertical, in Bangalore INDIA, MYLAN Inc. Director Validation & Tech Services, MGP a Wockhardt, Ltd, company. Built for the Aseptic Filling, Formulation Equipments and Computer Systems and IT-Automated Systems in RM. SME in FDA, TGA, EMA/MHRA Audits for Tech Transfer and Hospira Process Manufacturing Biologics Hospital Drug Shortage products. Managed and fostered a team of 25 Validation Engineers and Automation/Validation contractors. SME in ASTM E2500, Vision Inspections Systems, Wireless Technology Adaptation and QI contractors for all new API manufacturing. Wrote & managed the new site VMP, EMPQ and various PVP in Automation/ CSV, Equipment/Facility a World Class C&Q/Validation team for the Hospira Manufacturing & CMO facilities in the US Using complete adherence to the FDA for the Global Engineering - QA, C&Q and CSV Program Manager for the Automated Process Manufacturing Biologics- Vaccine facilities for newly Drug Development and RSV Monovalent Vaccines Projects in the US and OUS. Managed the newly launched HHS MHRA and OUS regulatory requirements. Fostered team building with the HHS Government site representatives contractors and consultants. Member of the FDA and MHRA Audit - Response Task Force team for the H1N1 and Flumist Vaccines.

Highlights:

• BMS
• CMOS
• Siemens
• Apollo
• Assembly Line
• Insulin
• Management
• Program Manager
• Project Management
• Quality
• QA/QC CSV