Decades of experience in pharmaceutical and biopharmaceutical industry with on-going involvement in compliance and quality systems. Extensive background in Gap/Risk Analysis, Baseline Audit of (Internal and CMO). Comprehensive review of the Quality Standards, along with Design for Six Sigma Activities, Software Validation, Aseptic/Fill F
Decades of experience in pharmaceutical and biopharmaceutical industry with on-going involvement in compliance and quality systems. Extensive background in Gap/Risk Analysis, Baseline Audit of (Internal and CMO). Comprehensive review of the Quality Standards, along with Design for Six Sigma Activities, Software Validation, Aseptic/Fill Finish Qualification, Cycle development (CIP, autoclave), Optical Recognition Firmware, SAP, SOP generation and training, Validation project management.
Our service focuses on having a holistic approach to the entire organization while treating each quality system as part of the synergetic unit rather than performing tasks in silos. Having a comprehensive understanding of intradepartmental and interdepartmental dynamic allows us to complete deliverables in the most efficient manner while maintaining COMPLIANCE with INTEGRITY.
Having such diversified experience in areas of Compliance oversight, Validation Project Management, GAP analysis makes us one stop for all Compliance and Validation needs.
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