• 23 years’ expertise in Pharmaceutical and biotechnology sector, with significant portion of the experience in Quality assurance and Quality control activities
 • Proficiency in cGMP design of facilities, VMP, commissioning and qualifying process systems associated with parenteral and biologicals
 • Experienced in presenting to various regulatory inspectorate – USFDA, EMEA, QP, PIC/S countries Health Authority with successful outcome
 • SME in the present organization for failure investigations related to microbiological and non-microbiological issues encountered in clean utilities such as Water for Injection [AWFI and HWFI], Purified Water and for classified cleanroom process areas 
 • Expertise in Facility layout cGMP/ design review for contamination and cross contamination control strategy – review of men, material and waste flow, AHU zoning, BLS segregation, classification, pressure differential and containment control via airlocks etc.
 • Experienced of working with multi-culture during my professional journey and a strong advocate of Diversity, Equity and Inclusion in the team