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 recuiterMember since Nov 11, 2022 Naveen Kumar P
from Gauteng, South Africa