Validation Lead for leading Pharma companies, worked on key deliverables like System Categorization, Documentation, System Categorization, Consultation/mentoring delivery teams, Management reporting, client facing roles.

Specific job functions: End to end Computer System Validation (CSV) planning, execution & Validation Consultation (both Paper and QC Based) Prospective and Retrospective Validation Regulatory compliance like 21 CFR Part 11, etc. Project Scope finalisation discussion with Client Project Management Ensuring project process and compliance Contract management, Resource management & Work estimation for CSV projects HW/SW requirements for Test environment… Show more Specific job functions: End to end Computer System Validation (CSV) planning, execution & Validation Consultation (both Paper and QC Based) Prospective and Retrospective Validation Regulatory compliance like 21 CFR Part 11, etc. Project Scope finalisation discussion with Client Project Management Ensuring project process and compliance Contract management, Resource management & Work estimation for CSV projects HW/SW requirements for Test environment Functional scope, Requirement Analysis, Impact & Functional Risk Assessment, Gap Analysis Defining Validation Test Strategy and Approach CSV Documentations (update / author documents like GxP Assessment / FRA / URS / VP / TP / OQ-PQ / RTM / TSR / VSR / WI) Support to Dev team during IQ phase Test Management Process improvements Defect Management and Defect Prevention Metrics calculations & monitoring Innovation Ideas, Reusable components Involvement in documentation for Vendor Audits Case Studies and presentations Various initiatives at BU level (Quality Circle, KSS, BU Portal conceptualisation & implementation, Healthcare Validation Trainings migration into BU Portals, Healthcare domain Validation Competency development for BU, etc.) Validation Testing Process improvement V & V team skills development on Healthcare KM culture development  Validation Support to maintain GxP applications in Validated state by periodic reviews, Change Control management for enhancements validation and documentation management----------------------------------------------------------------------------------------------------------------------------------------- Show less

Job Profile & Responsibilities: Division: Spirax Marshall Ltd., Pune.Worked in various Functional Areas as mentioned above with effective co-ordination and executions. It involved Fabrication projects executions and co-ordination with various departments like Sales, Costing, Commercials, Shop floor, Vendors, Dispatch, Quality, Stores, IT Support, Engineering, Maintenance, Service sections, customers, dealers, etc. Handling Fabrication projects (IBR & Non-IBR) Relevant IBR… Show more Job Profile & Responsibilities: Division: Spirax Marshall Ltd., Pune.Worked in various Functional Areas as mentioned above with effective co-ordination and executions. It involved Fabrication projects executions and co-ordination with various departments like Sales, Costing, Commercials, Shop floor, Vendors, Dispatch, Quality, Stores, IT Support, Engineering, Maintenance, Service sections, customers, dealers, etc. Handling Fabrication projects (IBR & Non-IBR) Relevant IBR Compliance documentation Material Management Inventory Management of Fabrication items Procurement of Fabrication items Review and prioritization of Fabrication projects Usage of Oracle (11i) for MRP / WO release / Transactions / internal SCM----------------------------------------------------------------------------------------------------------------------------------------- Show less

Job Profile & Responsibilities:Worked in area of Projects of Layout & Interconnection where responsibilities handled were as below: Design, maintenance & upgradation of Conveyors Material management Team Management TPM of conveyors & material handling equipment Process Improvement Co-ordination with Purchase/Stores/Shop… Show more Job Profile & Responsibilities:Worked in area of Projects of Layout & Interconnection where responsibilities handled were as below: Design, maintenance & upgradation of Conveyors Material management Team Management TPM of conveyors & material handling equipment Process Improvement Co-ordination with Purchase/Stores/Shop Floor----------------------------------------------------------------------------------------------------------------------------------------- Show less

Job Profile & Responsibilities:Worked on the project Modular Bridge for Combat Engineering section. It included Guidance from Scientist ‘E’ and interaction with other Scientists in different sections. During this tenure, responsibilities handled were as below: Conceptualization of different mechanisms Design of various linkages for material handling equipment (conveyors, cranes, etc.) Prototypes of the items Drafting Preliminary Design Report of the project 2D… Show more Job Profile & Responsibilities:Worked on the project Modular Bridge for Combat Engineering section. It included Guidance from Scientist ‘E’ and interaction with other Scientists in different sections. During this tenure, responsibilities handled were as below: Conceptualization of different mechanisms Design of various linkages for material handling equipment (conveyors, cranes, etc.) Prototypes of the items Drafting Preliminary Design Report of the project 2D drawings & 3D modelling----------------------------------------------------------------------------------------------------------------------------------------- Show less