- Performed discrepancy management – Ensure comprehensive investigations are performed properly assessed for known impact to product, cause and corrective actions.- Assess corrections and corrective actions for discrepancies are logical and properly executed to prevent re-occurrence. - Provides QA oversight for QC/Warehouse/F&E/Utilities - Lean Six sigma certified (Green belt)- MQA Team Lead- Ensuring day to day duites are carried out, delegation of duties, manpower planning, ensuring SLT are met (eg, Gloc due dates and batch record timely closure), attending ad hoc meetings as MQA representative. o MQA-DMT(Deviation management team) team lead for alignment- Ensure alignment practices and issue management regarding discrepancy management to ensure compliancy with SOP and policieso MQA-F6 RFT (Right First Time) team lead for alignment- Ensure alignment practices and issue management with respect to documentation, observation writing and floor practices to ensure compliancy with SOP and policies. o Regulatory audit support- MQA presenter, representative and strategic planningo Provided floor support – Real time discrepancy management, point of contact for providing quality advice to manufacturing, observation writing and documentationo Performed batch record review – Pre-weigh, media/buffer, main process (upstream/downstream) batch records for Lucentis (E.Coli), Herceptin/Avastin (CHO)o Trainer- Site GMP/GDP trainer for new hires during induction program, manufacturing review of batch records and observation writing training components.o Mentored new MQA – Trainer for batch record review, discrepancy management, facility restart/shutdown, document approvalso Provided QA oversight for GMP changes – Performed document approvals and change record reviewo Manufacturing experience - Trained in upstream processes and operations for CHO cell line (specifically in 1K to 20k scale bioreactors and harvest operations)

- Lean Six sigma certified (Green belt)- MQA Team Lead- Ensuring day to day duites are carried out, delegation of duties, manpower planning, ensuring SLT are met (eg, Gloc due dates and batch record timely closure), attending ad hoc meetings as MQA representative. o MQA-DMT(Deviation management team) team lead for alignment- Ensure alignment practices and issue management regarding discrepancy management to ensure compliancy with SOP and policieso MQA-F6 RFT (Right First Time) team lead for alignment- Ensure alignment practices and issue management with respect to documentation, observation writing and floor practices to ensure compliancy with SOP and policies. o Regulatory audit support- MQA presenter, representative and strategic planningo Provided floor support – Real time discrepancy management, point of contact for providing quality advice to manufacturing, observation writing and documentationo Performed batch record review – Pre-weigh, media/buffer, main process (upstream/downstream) batch records for Lucentis (E.Coli), Herceptin/Avastin (CHO)o Trainer- Site GMP/GDP trainer for new hires during induction program, manufacturing review of batch records and observation writing training components.o Mentored new MQA – Trainer for batch record review, discrepancy management, facility restart/shutdown, document approvalso Provided QA oversight for GMP changes – Performed document approvals and change record reviewo Manufacturing experience - Trained in upstream processes and operations for CHO cell line (specifically in 1K to 20k scale bioreactors and harvest operations)