Sr. Validation Software Specialist

The Senior Software Validation Specialist analyzes system solutions and authors validation protocols, reports, and other Software Development Life Cycle documentation.

The Senior Software Validation Specialist participates in the delivery of Software system solutions by assuring validation activities are conducted in a compliant and timely manner.

The Senior Software Validation Specialist reports into Corporate Quality and works closely with other groups to assure the total software solution delivered meets compliance requirements and expectations.

Duties and Responsibilities


* Authoring Software Validation documents including Validation Plan, System Level Risk Assessment (SLRA), URS/FRS, IQ/CONFIG/OQ/PQ Test Protocols, Retirement Plan, Periodic Review, Data Migration Plan, Traceability Matrix, and Validation Final Report.


* Partners and communicates effectively with business customers, IT groups, management, QA, and external vendors to validate system solutions addressing compliance with SOPs, and work instructions.


* Assists Software Business Process Owners (BPO), Application System Owners (ASO) and IT Infrastructure Owners (IO) to plan and manage validation projects including user acceptance testing.


* Performs pre- and post-execution QA checks of user acceptance test scripts and works with BPO, ASO, IO and within QA to resolve problems.


* Understanding of Computer Software Assurance (CSA) vs Computer System Validation (CSV) concepts.


* Validating spreadsheet, QMS, infrastructure and other IT systems


* Manages the documentation archive (paper-based and electronic) in an inspection-ready state.


* Provides guidance to the BPO, ASO, IO, and project organization regarding appropriate documentation practices and methods including creation of documentation, resolving deviation/defects for issues found during testing and documentation corrections.


* Maintains training materials and trains involved groups on software documentation and testing best practices, test coordination, and other topics as needed.


* CAPA Owner: Performs investigation, root cause analysis, defines Corrections/Corrective Actions and the associated Effectiveness Check.


* Co-auditor Internal and Software supplier audits


* Manages the Software Periodic Review Cycle which includes Audit Trail and User Access reviews.


* Other duties as assigned.

Supervision Given


* Directly supervised by the Quality Assurance Manager of Software Validation.

There are no direct reports for this role.

Education, Experience and Skill Required


* BS Degree.


* Minimum of 3 - 5 years' experience working in a regulated industry.


* Minimum of 3 years Software Validation experience.


* Knowledge and experience in gathering requirements, writing software validation documents, user acceptance testing, and working with business processes.

Training Required


* Must complete all required training for a Senior Software...