A opportunity has arisen within a leading pharmaceutical organisation for a Validation Lead to join them on a contract basis until the end of the year. This role will oversee the compliance element of the IT systems across thier two European locations.
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