Computer System Validation Specialist
Position Title: Computer System Validation Specialist
Position Location: London (Office), or Ontario (Remote)
Position Reports To: Project Director, IT
Department/Unit Name: Corporate Operations
The Computer System Validation (CSV) Specialist is responsible for leading all validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with computer system validation regulatory requirements (e.g. 21 CFR Part 11) is always established and maintained. This includes prioritizing, developing validation strategies, executing, maintaining and coordinating CSV activities, evaluation of software applications against design specifications and user requirements and serving as the liaison between the appropriate IT, operational business units and external 3rd party partners/vendors (where applicable) on validation activities, in order to ensure project expectations are properly set and met. The CSV Specialist will oversee testing execution and may author/support software related documentation such as requirements, validation plan/protocol, trackability matrix, test scripts/cases, validation summary report and release documentation.
AREAS OF RESPONSIBILITY:
Software and System Validation
- Execute software and system validation according to established Quality Assurance procedures
- Write software validation documents (plans, summaries, test cases, traceability matrixes, etc.) using standard operating procedures and good documentation practices
- Coordinate with other stakeholders during the validation planning and execution process to ensure that related activities (requirements gathering, testing) are planned and resourced appropriately
Defect and Deviation Management
- Management of defects/deviations/incidents in validation projects, including:
- Logging and organizing all defects/deviations/incidents identified during testing
- Running triage meetings with the required stakeholders to identify resolution – e.g., whether to fix and retest, or defer to a later release
- Ensuring the defect/deviation/incident log is updated with appropriate status prior to closure of the project for filing
- Coordinating and managing validation and qualification testing documentation review, approval signoff, execution and post-execution review
- Coordinate with IT, QA and applicable business units in the training of validation project team members on testing and validation policies, SOPs, practices and tools. This may include formal preparation of training materials, one-on-one training and classroom training.
Validation Life Cycle Management
- Provide guidance and assessment to ensure changes to validated systems are managed and documented in accordance with current corporate procedures and regulatory requirements.
- Keep current with relevant industry and regulatory requirements, guidelines and best practices.
Applicants should have a minimum of a College Diploma/University Degree and 3-5 years of relevant experience. The ideal candidate will possess experience in validation of GxP computerized systems and software development methodologies, preferably in the pharmaceutical, biotech or medical device environment. Further, the successful candidate will have experience in a matrixed environment and interactions with internal partners and vendors. Additionally, a demonstrated understanding of quality system principles (training, documentation, change control, validation and audits). Highly refined oral and written communication skills, as well as interpersonal skills are required. Working knowledge of relevant technology, tools, software and processes (SDLC), including automated enterprise testing tools is an asset. . Experience in working to Standard Operating Procedures is preferred
o Office-based (London)
o If remote-based, regular travel into London Office
*Accommodations for job applicants with disabilities are available upon request