Software Validation Specialist needed for SaaS company

Validation Specialist position involves designing, executing and concluding qualification studies as they pertain to Installation, Operational and Performance Qualifications as well as writing SOPs where applicable.

- Ability to design and develop validation strategies and plans
- Leadership on validation strategies for system implementations and changes to ensure solutions are demonstrated as fit for purpose
- Partner with the application owners and system implementation teams to ensure CFR Part 11 compliance
- Develop validation documentation such Validation Plans and perform Quality review and sign-off of computer system control documents
- Perform risk assessments for Intellect software systems
- Perform impact assessments for software systems to include classification against various regulations
- Review software change requests and test scripts
- Draft IQ/OQ/PQ software protocols
- Draft software validation plans
- Develop software trace matrices
- Prepare, review and approve various computer validation documents for CSV projects
- Ensure validation state of software systems are maintained
- Provide compliance / validation leadership to project teams
- Review and approve validation and test protocols for adequacy and completeness
- Proactively identify opportunities for process improvement in the Systems Life Cycle
- Act as subject matter expert for CSV compliance during internal and external audits
- Perform audit trail reviews


Knowledge and skills:
- Excellent knowledge of validation, quality assurance, information systems, and risk management best practices.
- Extensive knowledge of QA methodologies, test planning, system dependencies, and product integration phases
- Strong knowledge of QA methodologies, test planning, system dependencies, and product integration phases.
- Knowledge of regulatory requirements for non-product and product software (IEC 62304, 21 CFR Part 11, etc.)
- Excellent communication, interpersonal skills, and customer focus
- Must be well organized and willing to work as part of a team
- Test automation experience a plus
- ASQ CSQE a plus
About the recuiter
Member since Jul 6, 2017
Mark S.
from Bergamo, Italy

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