Project Associate-Regulatory and Legal Support-Corporate Compliance & Operational Risk (10099)
- 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.