Project Associate-Regulatory and Legal Support-Corporate Compliance & Operational Risk
Location: Boston, Massachusetts
Internal Number: 16224175
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.
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
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
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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