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Validation Specialist III- Infrastructure environment

Company Name:
Tech Observer
Roles and responsibilities: Job Code: Validation Specialist III
Job Title: Validation Specialist III
Duties:
Operational IS Quality Activities:
Infrastructure Change reviews/approvals
Infrastructure project support
Validation/Qualification experience in an Infrastructure environment:
Experience with SDLC lifecycle methodology
Experience with reviewing validation deliverables
Previous migration validation experience is a Plus
Hands-on experience w/ Change management and change control
Knowledge of Remedy Application BMC suite
Technical Writing:
Experience with developing high level validation deliverables such as Validation Plan and Summary Report, etc.
Reviewing and collecting Audit pre-documentation
Experience with documentation practices. Documentum/Sharepoint experience is a plus.
Skills:
Demonstrates a working knowledge of continuous improvement knowledge and best practice.
Accountable for providing metrics (Change Management, reporting documentation forecasting and tracking).
Lead and assist in Complex Infrastructure and QC projects.
Drives documentation and reporting status to completion.
Demonstrates an understanding of an EDMS and related access approval and provisioning.
Serves as coach and mentor to the project team.
Serves as a resource to the project team on Quality and compliance issues regulations related to testing and documentation for systems.
Good knowledge of GDPs.
Must be able to engage with cross functional team members
Must demonstrate the ability to multi-task.
Has a strong working knowledge of testing process, designing test scenarios and test scripts, including an overall understanding of various software quality practices with the ability to learn and apply new and emerging concepts very quickly.
Drives test execution review and status reporting.
Has developed a broad understanding of the infrastructure environment; to apply an understanding of the interoperability of systems and technologies for the testing/validation effort.
Anticipates project changes and escalates accordingly.
Demonstrates effective time management skills and effectively meets or exceedes project deadlines.
Education:
Developing and documenting User, Functional and Design requirements; Installation.
Operational and Performance Qualification protocols and reports; Standard Operating.
Procedures; requirements traceability; Infrastructure Qualification and change control.
Leading and managing people who perform qualification/validation activities in accordance with requirements, procedures and protocols.
Providing training and support to IT staff on change control, issues and audit preparation.
Collaborate with regulatory specialists in Quality and Compliance to develop IT methodology to implement compliance in an efficient manner.
Demonstrate a working knowledge of CAPAs, RCAs, and process deviations.
College Degree
Thanks & Regards !
Sonam Chaturvedi
Resource Specialist
Tech Observer
Direct: 201-464-4888
Ph: 201 489 7705 x 116
Fax: 201 215 9587
sonam.chaturvedi@tech-observer.com
www.tech-observer.com/

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