Validation Tester
ITAS, INC - Indianapolis, IN

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Job Title Validation Coordinator Relevant Experience (Yrs) Min 5 years experience in IT QualityValidation TechnicalFunctional Skills · Understanding of IT validation process in a Pharmaceutical IT environment · Understanding of GxP system validation · Understanding of CFR part 11 and other regulatory compliance requirements · Documentation experience · Knowledge of document management using documentum or Regulas · Using quality center software for testing and validation · Remedy or other service management tool · Understanding of various software lifecycle models Experience Required · Experience in IT Document Validation · Experience in IT processes and regulatory compliance · Experience in Document Change Control Procedures · Experience providing end to end validation support for IT projects Roles Responsibilities · Analyze the validation requirements for each project request from customer and advise the customer on appropriate validation approach · Primarily responsible offshore coordination of validation activities within the customer organization · Responsible to allocate the validation activities to offshore team review the deliverables from offshore team and ensure that validation deliverables meet customer expectations · In addition responsible for creating reviewing updating and approval coordination of Deliverables for certain critical projects · Responsible for providing consultation on usage of Deliverable’s templates SOPs guidelines and checklists · Responsible for reviewing test results and test evidence to ensure testing completion · Coordinate with customer’s quality integrators for work projection issue resolution and other support activities · Responsible for assisting business team in preparing and conducting the User Acceptance Test cases Generic Managerial Skills Time management communication work allocation and status monitoring Good oral and written communication skills Education Degree in any field Certification in Quality Processes Management will be preferred Pls foward the resumes to siriitascorpcom or call me 8475980705 Validation Testing