Required Accuracy Verification,Software Quality Management (SQM),Systems Development Life Cycle (SDLC),Agile Project Management,Requirements Specification freelancer for Software Validation Specialist for SaaS company job
Posted at - Feb 3, 2023
Toogit Instant Connect Enabled
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 Choriyanto Sumodiharjo from Cherkasy Oblast, Ukraine