We are looking for 1-2 Validation Managers to help our client with the compliance part of IT-systems.
- Ensuring that the criticality of the system is evaluated and documented
- Work closely with QA to ensure the overall quality assurance
- Managing and driving the validation effort
- Contributing to the project plan for the validation phase
- Facilitate and report Risk Assessment and maintenance of the risk register during the project phase.
- Produce the Validation Master Plan, Validation Plan and the Validation Report
- Ensuring quality of deliverables (User Requirement Specification, Functional and Technical design Specifications)
- Establishment and approval of IQ and OQ, PQ protocols and –reports
- Creation of Traceability matrix (TRM)
- Creation and/or management of requirements, test sets and test cases, defects and traceability matrix using MicroFocus ALM tool
- Support LoB and IT in writing/review IT SOPs such as IT administration, or/and IT operation and maintenance SOPs
- Ensuring adherence to good documentation practice in test cases writing and execution
Start: April 2021
Duration: End of 2021
Location: 100% remote due to corona. When possible again location is onsite.