* Computer System Validation Specialization as per GAMP5, 21 CFR Part11, EMEA and CSA* Commissioning and Qualification of Process Equipment* Risk Assessment as per ICH Q9* Facility Qualification* Cleaning Validation Specialization* Process Validation Specialization* Electronic Log Book Specialization* SAP Project Management, PP & QM Consultation and CSV.* Manufacturing Specialization in API and FormulationMaster mind in designing of cleaning validation, process validation, computer system assurance, electronic log book software and validation lifecycle management system. Computer System Validation & Part 11 Compliance (V&V): Hands on experience in Verification and Validation of the computer system starting from preparation of Validation Master Plan, Gap Analysis, Risk Assessment, Mitigation Plan document, Traceability Matrix, IQ & PQ Protocol, Testing document and Validation Report as per the classification of GAMP 5, USFDA guidelines and Good Documentation Practice.Expertise in ValGensis Validation Lifecycle Management System, Process Manager - Cleaning and Process Validation, iRisk, iSee, Electronic Log Book, VConnect Softwares.Regulatory: Expertise in Regulatory Standards of ICH, USFDA, EMEA, ISPE, PIC/S, TGA. Worked in eCTD (Docubridge), SPL-PLR, SAP, Orcale Clinical applications.SAP: 11+ years of experience in SAP Validation, Business Consultant and Functional Expertise in PP & QM ModuleProject Management: Experienced in End to End Onsite - Offshore Project Management, starting from Requirement Gathering, Knowledge Transfer, Project Plan Preparation, Identifying the Deliverables, Project Documentation, Client Communication, Team Building, Project Execution, Project Close Out and Business Continuity.Business Analysis: Highly experienced in customer interface and interaction, understanding the business requirement, designing the business model, documentation of User Requirement Specification (URS), Functional Specification (FS), Process Flow Diagram, Data Flow Diagram and Business Use Cases.Process & Facility Validation: Experienced in validation of Pharmaceutical Manufacturing Process, DCS, PLC, SCADA, BMS, HVAC Systems.Pharma Manufacturing: Highly experienced in pharmaceutical manufacturing (Bulk Chemicals, API & Formulation - sterile & non-sterile) from Scale up of process, Validation batches, commercialization and logistics. End to End experience in Supply Chain Management, Production, Quality Control, Quality Assurance, Validation, Technical Management, Project Management, MIS, Good Documentation, and Sales & Marketing.