Deloitte Job - 30874339 | CareerArc
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Company: Deloitte
Location: Parsippany Troy Hills, NJ
Career Level: Associate
Industries: Business Services, Consulting

Description



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IT Quality Project\nAssociate – Sr. Consultant Level

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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.

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Key\nResponsibilities:

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  • 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

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Key skills required:




Must Have:


  • 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.








Benefits

At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.







Deloitte's culture

Our positive and supportive culture encourages our people to do their best work every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer well-being programs and are continuously looking for new ways to maintain a culture where our people excel and lead healthy, happy lives. Learn more about Life at Deloitte.





Corporate citizenship

Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships with our clients, our people and our communities. We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte's impact on the world.





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#IND:PTY


As used in this posting, “Deloitte Advisory” means Deloitte & Touche LLP, which provides audit and enterprise risk services; Deloitte Financial Advisory Services LLP, which provides forensic, dispute, and other consulting services; and its affiliate, Deloitte Transactions and Business Analytics LLP, which provides a wide range of advisory and analytics services. Deloitte Transactions and Business Analytics LLP is not a certified public accounting firm. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. These entities are separate subsidiaries of Deloitte LLP.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.

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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