Sr. Validation, DI, and Compliance consultant role

Sr. Validation, DI, and Compliance ConsultantDuties include:DI PROGRAMPerform Data Integrity assessments and document the results based on industry guidanceWork with Gilead Partners to facilitate the development of remediation plans, train, and assist with the execution of the planSupport, train, and execute a remediation approach that can be operationalized within GileadVALIDATIONWork with facility Subject Matter Experts to document user requirementsUpdate application system User Requirements, Functional, and Design SpecificationsDevelop Installation Qualifications based on DesignDevelop Operation Qualifications based on functional requirementsDevelop Performance Qualification scripts based on configurationRoute validation documentationManage Tasks based on aggressive timelinesInteract with multiple stakeholdersInteract in team environmentQualifications10-15 years' experience in computer systems validation within the Life Science arena preferably in the Pharma space in the areas of Quality Assurance and control, IT, and Manufacturing.Minimum BA / BS or relevant work experience in information systems, engineering, science or business.Excellent oral and written communication skills.Thorough understanding of the principles of computer systems validation, SDLC, VLC methodologies.Extensive Knowledge of cGxP, GDP, GAMP, 21CFR Part11, Annex 11, MHRA guidance, and industry best practices.Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.Strong communication and interpersonal skills ensuring the ability to interact with the business, peers, and vendors in a professional manner.Ability to work independently with minimal supervision.Consistently meet the agreed timelines with high level of quality