Back to jobsResponsible for the day-to-day activities conducted by the Validation department.
Provide leadership on the activities of the internal validation staff as well as external validation contractors.
Lead team member assignments to assure tasks are completed accurately and to schedule.
Establish priorities to ensure that deadlines are met, and budgets are not exceeded.
Oversee the site Validation Master Plan, using input from internal and external resources for continuous improvement.
Create, coordinate, maintain and enforce Validation systems, policies, and procedures.
Participate in audits and inspections conducted by internal and external entities.
Able to correctly assess all change controls with an accurate understanding of the bigger picture implications of changes
Review and approve all business unit validation testing and documents for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data.
Ensure all revalidation requirements are met for equipment, process, and cleaning site wide.
Manage the revalidation program.
Team member for new product introductions, regulatory compliance initiatives, implementation of process improvements.
Forecast and manage project work correctly and independently; able to be an independent interface to other portions of the organization as assigned, providing updates as requested and seeking out higher level input when it is necessary; scope of projects managed is large and complex.
Write and review policies or procedures for compliance with regulatory guidance.
Active leader and decision maker, as needed, on internal projects related to formulation, filling, environmental, facility improvements and developing new approach to business.
Work with Regulatory Affairs to prepare Regulatory Submission Documents for project initiatives.
Lead initiatives to streamline processes and workflow by initiating Operational Excellence initiatives.
Interact with management, senior management, and stakeholders to determine project scopes, timelines, and prioritization of global and local projects.
Manage validation activities for large scope capital projects (including Turnaround projects) that encompass multiple protocols and/or a validation plan.
Direct supervision of contractors or other specialists.