Manjunath Akki Email & Phone Number

18+ years broad-based Quality professional with experience in the Clinical Trials Materials (CTM) and Commercial Products. Effectively manages multiple QA functions including batch disposition, change management, training, and document control. Active participation and engagement in regulatory inspections US-FDA, EMA, PMDA and over 5 Pre-approval and GMP compliance inspections. In depth knowledge of GMP QA operations, validations, and quality systems. Expertise in establishing quality agreements and technical agreements with CMOs and business partners. • Batch disposition and QP release• Root cause investigations and CAPA • Contract manufacturer quality oversight• Process and cleaning Validation • Change control program management • Supplier Quality management • GxP auditing • Regulatory inspection management • Quality and supply agreements • Quality Risk management

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  Rajiv Gandhi University Of Health Sciences

  Pharmacutical Chemistry