Purpose Statement: responsible for leading the site in planning and executing equipment, process and product validations in accordance with all applicable regulations, standards and customer requirements.
Key Job Accountabilities:
•Maintain the site Validation Master List (VML)
•Determine the validation strategy for product Validation Master Plans (VMP) in accordance with sector specific and customer requirements
•Support the maintenance and update of product VMPs
•Train identified users in the validation process
•Coach trained users in best practices and the use of appropriate statistical analysis tools to develop validation skill set at the site
•Provide practical expertise and technical guidance in creation and execution of validation protocols
•Determine and coordinate validation activities required as a result of site changes
•Provide timely review and approval of validation documentation
•Maintain a working knowledge of all validation requirements, practices, procedures and industry trends for validation process and development.
•Escalate issues and roadblocks that are preventing progress and success
•Maintain and report validation metrics
•Provide data and SME input in to the site Quality System Management Review, Metric Dashboard and Operations reviews as appropriate
Additional Accountabilities: •Support site internal audits & Support customer visits and audits •Support external registration or agency
audits and Regulatory Inspections. •Actively Participate in the Global
Validation user Group.
•Support site internal audits & Support customer visits and audits
•Support external registration or agency audits and Regulatory Inspections.
•Actively Participate in the Global Validation user Group.
Skills and qualifications:
•An Engineering Bachelors is highly desired.
•Experience on the same role is highly desired.
•Systems Training: Train the organization to use Supply Chain related tools and concepts.
•Create necessary training documents to document standard processes and procedures involved in the day to day use of the system. Provide training to those who will need to be able to properly use and/or execute tasks using the system