Sr. Validation, DI, and Compliance consultant

Sr. Validation, DI, and Compliance Consultant

Duties include:

• DI PROGRAM
• Perform Data Integrity assessments and document the results based on industry guidance
• Work with Gilead Partners to facilitate the development of remediation plans, train, and assist with the execution of the plan
• Support, train, and execute a remediation approach that can be operationalized within Gilead
• VALIDATION
• Work with facility Subject Matter Experts to document user requirements
• Update application system User Requirements, Functional, and Design Specifications
• Develop Installation Qualifications based on Design
• Develop Operation Qualifications based on functional requirements
• Develop Performance Qualification scripts based on configuration
• Route validation documentation
• Manage Tasks based on aggressive timelines
• Interact with multiple stakeholders
• Interact in team environment

Qualifications

• 10-15 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, 21
  
  CFR Part
  11, 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