Indrajit Patil

1) Deviations handling through effective investigation, impact assessment and closure of deviation with appropriate CAPA. 2) Preparation & review of SOPs & protocols as per revision dues or pharmacopoeia updations and its implementation. 3) Change control management through its review, approval, timely implementation of change and its closure within timeline. 4) OOS handling through effective preliminary investigation, root cause investigation by scientifically sound approach and closure of OOS with effective CAPA. 5) Review of Corrective and preventive actions on non-conformances related to deviations, internal/ vendor/ regulatory audit observations and market complaints investigation. 6) Review of market complaint investigations. 7) Review of risk management e.g FMEA. 8) Communication with contract givers and vendors on any non-conformance, validation studies and change controls etc. 9)Review of microbiological limit test of formulation products, raw materials, water samples, stability, environmental monitoring reports & trend data of water analysis and environmental monitoring. 10) Preparation of Microbial limit tests (MLT) method validation protocols & verification protocols and its implementation. 11) Training to sub-ordinates on SOPs, policies and active participation in compliance activities. 12) Responsible for implementing cGMP practices in laboratory, assuring implementation of ALCOA principles by detecting and preventing data breaches in every aspect. 13) Lead escort of department during regulatory, internal & customer audits.