Job Summary
GP&T Lead worked with site GP&T leads to support all operations related technical requirements. Support for failure investigations and its reduction, Process improvement with respect to robustness
Areas of Responsibility
Co-ordinate with all Site GP&T team for GP&T functions.
Work plan preparation and tracking for GP&T activities.
Provide technical support for the investigations of OOS, OOT, Trouble shooting and unplanned deviation of all API manufacturing sites for root cause identification.
Co-Ordinate with AD/R&D for impurity identification. Should have knowledge of technique of Characterization.
Coordinate with RA for technical requirement for additional filing/ Query response.
Coordinate with site quality team for regulatory audit preparation and to provide technical support during Audit.
Participate for PSD/BD and TD related failure with R&D and process Eng.
Work on process robustness and reduction of repeated failure
Support for reprocess method development for inventory liquidation.
Update and maintain GP&T tracker.
Budget preparation and maintaining.
Provide technical support for LCM technology transfer
Co-ordinate & Monitor with site GP&T team for Vendor qualification, Inventory reduction, Control of yield loss, EHS related activities, Solvent recovery etc