Validation Coordinator QA
ITAS, INC - Indianapolis, IN

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Hi, Please send any relevant resume for the below requirement to Role Validation Coordinator Location Indianapolis IN Duration Long Term Job Title Validation Coordinator - QA 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 Thanks Regards, Sridhar ITAS Inc, 9000 Keystone Crossing,Suite 150, Indianapolis, IN 46240. Work 317-575-8950 Extn 4244 Fax 317-575-8953 Fax(eFax) 630-566-0636 validation , QA, CFR Part 11, IT document validation