. Collaborative support to @ WHO-Gates foundation-BCG initiatives for sourcing complex drugs for the poor across the Globe @ McKinsey-Cadila pharma initiatives for 'work in simplified eco-system leveraging automation (WISE)' program.
. Strategic remediation of WI/ Import alert: Megafine Pharma, Apotex, Hetero, Syngene (Biocon), Malladi, Torrent, Sai Life Sc, Centrient Pharma as collaborative effort.
. Facilitated USFDA, MHRA, PIC/S, ANVIZA, INVIMA, CIS and GCC certification successfully for Hetero Drugs, Aurigene (DRL), Wockhardt Biotech, Wintac, Aizant, Unichem, Virchow, Biocon Biologics and Steril-Gene.
. Lean laboratory and Process throughput management in Emcure, Cipla, Amneal Pharma, Wockhardt, Geltec, Cadila Pharma, Pfizer Ltd.
. Investigation of ALCOA and Data integrity breach in the prevailing QMS and ANDAs and addressing the deficiencies with the relevant CAPA as per the current EU and US regulations in Aizant Drugs.
. Greenfield project C&Q, validation and training support to Aurigene, Aizant, Virchow, GeneSys, GAAR, Centum, Bajaj Life Sc.
. Systematic FMEA and HAZOP risk assessment for the API and Solid orals manufacturing of Sai Life Sc and Evertogen
. Technical due diligence audit of the Vaccine manufacturing of GSK-CBPVL, Pharbaco JSC (Vietnam), MoH Myanmar Snake Venom lab, Bajaj Life science API facility, RL Fine Chem, Kalbio Malaysia, Aurobindo, DRL, etc.
. Vendor/ Supplier audit: Syngene, Sai Life Science, Anthem Bioscience, Eurofins Advinus, Gland Chemicals, Lake Chemicals, GVK Life – Inogent, Vindhya Organics, PADM Lab, Hisun Pharma, Biomab Shanghai, Stellence etc.
. Designed training matrices, conducted training and evaluated learning effectiveness to 200 SMEs on Clean room practices at Sterlite Technology, to 100 SMEs on GMP in Shanghai and Nairobi, to 50 SMEs on QMS at Wockhardt, Micro Labs, Sai Life Science, Cipla and Unichem, etc.
. Implementation of QMS for the Medical devices manufacturing of Sensa Core, Diabetomics, etc.
. Teamed collaboratively with McKinsey Inc, Boston Consulting, FlexingIt, IQVIA, PharmaLex and Koncepo Int as an Expert.
. Remote & Virtual support to Clients on digitalization & automation in QS, investigation, regulatory audit preparation, training, etc.
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