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Manu Walia

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I am a seasoned IT Advisor, Strategic Thinker, Solution Owner and Avid Learner with over 16 Years of experience in managing multi-disciplinary teams of varying sizes and complex programs of Data Integrity, Quality Assurance, Computer System Validation, Process Compliance, Quality Assurance, Project Management, Business Process Analysis, Process Framework development, Risk Assessment and Profiling, Process Re-Engineering, Reviews, Audits, GxP, Regulatory Compliance against FDA - 21 CFR Part 11 and GAMP 5.0 Framework in Pharmaceutical / Medical Device IT Compliance & Quality environment. I have consulted globally for Top 20 pharmaceutical companies and advised in the Computer System Validation, Project Management and Quality Assurance in the following Business / IT functions but not limited to: - Enterprise Resource Planning - Supply Chain Planning - Pharmacovigilance - Serialization and Track & Trace - Pack Management - Manufacturing and Packaging - Laboratory Information Management - Electronic Document Management - Electronic Change and CAPA Management - Electronic Signature implementation for GxP processes - Data Center and IT Infrastructure Commissioning - Retirement and Decommissioning - Quality Management Setup I have rich experience in aligning business processes and systems with corporate strategy; ensuring overall IT infrastructure, landscape and roadmaps are integrated and supportive to business; leveraging cloud technology and service models to improve efficiency and reduce total cost of ownership. I also have broad experience with vendor selection process (RFP), setting up contractual agreements (MSA/SOW), on-premises, and cloud-based software providers; identifying and developing high-quality start-ups and managed service providers for growth and strategic partnership.

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