Project Associate-Regulatory and Legal Support-Corporat

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Deloitte
Project, IT, Quality, Systems, Excel, PowerPoint, FDA, SAP, Manager, ISO, SDLC, Validation
Full Time

Job Description

We help clients align their people, process, and technologies with business objectives, and to improve and transform their operations and operational risk programs in a strategic and efficient way. In doing so, organizations can focus on what is important, anticipate risk, and enhance their overall operations to support their strategic objectives and bolster their risk preparedness. We are currently looking for Project Associates to performing a variety of IT Quality This is a 1-2 year assignment located in New Jersey.

Key Responsibilities:
  • Ensures documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies.
  • Review functional or technical requirement documents and develop test cases to the stated requirements including positive and negative testing.
  • Review the accuracy and completeness of software validation deliverables created by other process teams (e.g., Requirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)
  • Create Traceability Matrices linking approved requirements to test cases in HPQC (both automated and manual).
  • Works with fellow validation and project team members in a dynamic environment with shuffling priorities and responsibilities.
  • Provide expertise in the review of all deliverables across the project lifecycle, ranging from requirements documentation to final protocol reports.
  • Keeps the validation lead informed of any issues regarding the quality of the deliverables, or any potential sources of impact to the project timeline.
  • Accurately report the status of assigned deliverables and support other compliance work as necessary


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
  • Travel up to 80% (While 80% of travel is a requirement of the role, due to COVID-19, non-essential travel has been suspended until further notice)
  • Limited immigration sponsorship may be available

Preferred:
  • 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.


Company Information

Deloitte provides industry-leading audit, consulting, tax and advisory services to many of the world’s most admired brands, including nearly 90% of the Fortune 500® and more than 7,000 private companies. Our people come together for the greater good and work across the industry sectors that drive and shape today’s marketplace—delivering measurable and lasting results that help reinforce public trust in our capital markets, inspire clients to see challenges as opportunities to transform and thrive, and help lead the way toward a stronger economy and a healthier society. Deloitte is proud to be part of the largest global professional services network serving our clients in the markets that are most important to them. Now celebrating 175 years of service, our network of member firms spans more than 150 countries and territories. Learn how Deloitte’s more than 330,000 people worldwide connect for impact on our website.

Dice Id : 10106525
Position Id : 10099
Originally Posted : 6 months ago

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