IT Validation Specialist
2 weeks ago
We are seeking a highly skilled IT Validation / Business Analyst to join our team at Lifelancer. This role will be based at our Cambridge site or remote, and will be responsible for business analysis and validation of our GxP applications.
Key Responsibilities- Business analysis and validation of GxP applications
- Knowledge and experience with Veeva Quality Vault (QDocs, QMS, LMS), and Lab Information Management system (LIMS) or other lab systems
- Deep understanding of the software development life cycle and computerized system validation principles
- Knowledge of science biology, chemistry, engineering, or related discipline
- Experience working in a GxP regulated environment, preferably in the biopharma space
- Experience working with users from the quality, clinical, and regulatory domain
- Experience working with Veeva Systems and SaaS applications
- Experience working with LIMS or other lab systems
- Comprehensive understanding of the Software Development Life Cycle, GAMP 5 and regulatory agency requirements
- Knowledge in following areas: business analysis, user requirements analysis, system development life cycle (SDLC) and validation requirements
- Comprehensive understanding of GAMP 5 risk-based approach to GxP system validation
We offer a dynamic and collaborative work environment, with opportunities for professional growth and development. If you are a motivated and experienced IT Validation / Business Analyst looking for a new challenge, please apply via the Lifelancer website at the below link for screening steps and quicker response.
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