Hi All,I am actively looking for a job as a Computer system validation analyst. I have overall 9 years of experience in pharmaceuticals, biotech, drug and device manufacturing industry with software development lifecycle.I am a post graduate in Masters of Science.Please connect to me if any vacancy is available, I am summarizing key responsibilities I performed till date for your reference.Good exposure on Life cycle documentation and am responsible for tracking, monitoring and controlling the validation process to ensure timely and cost-effective delivery of the system to the business users /customers.Responsible for Prepare and/or review all levels of CSV validation documents including: Validation Plans, User Requirement Specifications.Review of High Level risk Assessment includes GxP Assessment and GAMP categorization, criticality Assessment, ERES Applicability Assessment etc.Definition Documents, including Functional Specifications, Design Specifications or Configuration Documents and SOPs, VMP and VP.21 CFR Part 11, EU annex 11 assessments for Process systems.Validation Reports, Change Controls/ Events / Deviations.Experience in various Software Development Life Cycle (SDLC), Like Waterfall, V-Model, and Agile methodology.Expertise in documenting Design Review and Qualification Protocol, Technical Writing.Excellent experience as Validation Specialist and in-depth involvement in writing test scripts for Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).Providing the guidance/support to internal teams for external/Regulatory Audit preparation/Audit compliance.Experienced in Periodic review to confirm that the computerized system remains in a valid state and is compliant with regulatory and standard requirements.Review of Defect/Deviation management and CAPA Management.Various Models of Cloud computing like SaaS, PaaS, IaaS and their Validation Approach.Responsible for participating in validation projects in adherence to applicable globalregulatory requirements, company policies and standard operating procedures.Ensure computerized systems are appropriately validated.Participate in process improvement and risk management activities for automated systems and maintenance of a compliant, efficient and integrated system until system retirement.Experience in Validation of PLC, DCS and SCADA control systems. Good Knowledge on 21 CFR Part 11, EU Annex-11 and GAMP 5.Knowledge on PLC, DCS (PCS7) and SCADA programming.Thank you, 😊