- He/she must have a minimum 6-8experience in the field of Computer system validation
Some of the responsibilities include:
- Responsible for validation support for other systems and projects.
- Develop validation plan, validation protocols, traceability matrices, test summaries, acceptance criteria and compile data and results into final validation summary report. Track deviations and Change Controls.
- Provide guidance, training, and support to IT personnel / business users in their validation efforts, to ensure compliance. Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies.
- Review proposed changes to validated systems and identify the validation requirements necessary to maintain the system?s validated state. Coordinate registration of documents with Global Quality Assurance(GQA) Document Control organization.
- Supportinternal and external audits and periodic reviews. Collaborate with the business on needed SOPs and good documentation practices.
- Expertise is GxP documentation