IT Quality Project\nAssociate – Sr. Consultant Level
We\nhelp clients align their people, process, and technologies with business\nobjectives, and to improve and transform their operations and operational risk\nprograms in a strategic and efficient way. In doing so, organizations can focus\non what is important, anticipate risk, and enhance their overall operations to\nsupport their strategic objectives and bolster their risk preparedness. We are\ncurrently looking for Project Associates to performing a variety of IT\nQuality This is a 1-2 year assignment located in New Jersey.
Ensures documentation and practices meet\nquality standards, applicable regulatory compliance and company\nguidelines/policies.
Review functional or technical requirement\ndocuments and develop test cases to the stated requirements including positive\nand negative testing.
Review the accuracy and completeness of\nsoftware validation deliverables created by other process teams (e.g.,\nRequirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)
Create Traceability Matrices linking approved\nrequirements to test cases in HPQC (both automated and manual).
Works with fellow validation and project team\nmembers in a dynamic environment with shuffling priorities and\nresponsibilities.
Provide expertise in the review of all deliverables\nacross the project lifecycle, ranging from requirements documentation to final\nprotocol reports.
Keeps the validation lead informed of any\nissues regarding the quality of the deliverables, or any potential sources of\nimpact to the project timeline.
Accurately report the status of assigned\ndeliverables and support other compliance work as necessary
Key skills required:
Experience with IT Systems lifecycle (development, testing, implementation) – Quality assurance domain preferred
Knowledge of software testing
Exposure to cross functional teams (lead, co-ordination)
Ability to deal with all employees and external business contacts while conveying a positive, service oriented attitude
Attention to detail, quality, time management and customer focus
Interpersonal and ability to operate effectively in a matrix environment
Ability to write, read, and understand business as well as technical requirements
Experience with MS Office applications including: Word, Excel, PowerPoint
Nice To Have
At least 3 years of computer system validation in a pharmaceutical/medical devices environment
Experience in the validation of software tools in a FDA regulated environment.(e.g., SAP, SAP Solution Manager, and HPQC.)
Knowledge of regulations and software lifecycle approaches 21 CFR Part 11 and ,QSR's, ISO 13485, 21 CFR part 11,820,807,803 GAMP, SDLC methodologies)
Experience in development of Validation Master Plans for simple systems or facilities.
Experience in Project execution within at least one area of systems validation – e.g., laboratory equipment, facilities, utilities, manufacturing equipment, metrology equipment, information systems.
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Deloitte will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws. See notices of various ban-the-box laws where available. https://www2.deloitte.com/us/en/pages/careers/articles/ban-the-box-notices.html
Requisition code: E20NATAACSNF001-PA
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