- Manage the Computer System Validation aspect of IT projects from software install to business release
- Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration.
- Responsibility for server installations and system related activities e.g. security, admin config settings, access permissions
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines.
- Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
- Work with the business to identify and implement procedural controls to mitigate issues found during testing
- Initiate and implement Change Control activities in accordance with Quality Standards and Practices. Determine solutions or recommendations for changes and/or improvements.
- Prioritize validation activities in line with the project schedule.
- Collaborating with global IT and Quality teams
- Following all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
- Should anticipate being on site at least 75% of the time with limited remote work.
- Individual would be responsible for review / approval of vendor purchased computer system validation documentation.
- Additionally, the individual would help with preparation of any CSV protocols where the service was not provided, as well as any "addendums" required. Field execution would be managed by other personnel.
- Minimum 5 years' experience implementing IT solutions, systems integration, support & validating IT applications and interfaces.
- Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
- Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines
- Experience of OSI PI is an advantage.
- Experience of data analytics and reporting solutions is an advantage.
- Experience of server and workstation platforms and working in a Win 10 environment
- Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
- Self-motivated, detail-oriented, and excellent organizational and time management skills
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