- Manage Computer System Validation projects from software install to business release
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
- 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
- Minimum 3-5 years’ experience validating IT applications e.g. requirements gathering, design documentation, test case development, system & acceptance testing
- Past proven experience engaging business users to ensure that appropriate business needs are clearly defined, communicated and delivered at or above expectations
- Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
- Experience of SQL databases is an advantage
- Experience of analyzing and challenging s/w to identify gaps.
- Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
- S/he is expected to be self-motivated and develop an understanding of the business.
- Self-Motivation, use initiative to identify and drive improvements
- Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.
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