Amit Puri
Manager Q&C
quality control
Pharmaceutical Companies of Johnson and Johnson
United States of America
Biography
Lead the analytical laboratory, responsible to co-ordinate with cross functional team for timely release of the material/product & flawless execution of the projects (NPIs & other regional initiatives), Review of analytical reports, IQ, OQ, PQ and Calibration data of all instruments. SOP preparation & Training. Lead the analytical team of lab and responsible for •Oversight of lab and its upkeep-Like Laboratory Chemicals, Lab Calibration, Laboratory Standards, AMC of lab instruments, Management of GxP Documents and printed stationery •OOS/OOT Management •Implementation of local & worldwide standard quality procedures & Training of the staff •Management of Q&C operation cost (Opex & Capex & Annual budgeting) •Resource management-shift planning •Planning and execution of AMV •Material and Product disposition •Compliance assessment of the relevant SOPs/TMs/Specification applicable for the lab •Method Validation and Analytical Method Technology transfer •Member of site Process Validation team •Audit of Vendor and Suppliers •Member of JnJ International Analytical Community & SAP community •Market complaint investigation •Deployment of Quality System like GCC/NC/CAPA •Management of plant stability study •Compliance to site validation scheduler •Laboratory records & documentation management •Laboratory retention sample management •Support to R&D and SMP / TT for New Product/ Process development •Laboratory EHS compliance •All time readiness of the lab for internal/external audits
Research Interest
analysis
