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Sanjaya Nanjundaiah
Tech Lead, Quality & Compliance - No deviation
Professional Bio
• 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
• 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