-Participate in Project facility design development process
• Supporting requalification process’ for facility related areas – such as HEPA filter through third parties
• Supporting any facility maintenance or contamination control activities: review / approval / verification
• Drafting, reviewing, owning, and approving Facility and QMS Documents/Procedures to compliance requirements.
• Working closely with project managers, global sterility assurance, production and maintenance teams to perform troubleshooting and resolve facility design or damage issues.
• Lead Internal audits and audit teams
• Create and Complete Audit reports in ComplianceQuest
• Create and Manage CAPAs associated with Internal or External audits
• Host / Participate in external audits when necessary
• Act as QMS SME for Plant questions or concerns with reference to Regulatory Standards
• Develop and Maintain Pest Management through QMS compliance regulations
• Identifies, plans, recommends, and completes quality programs involving innovative applications and extensions of existing and new technologies of major importance to division business.
• Maintains extensive network of resources (laboratory, manufacturing, engineering, sales and marketing) to facilitate completion of assignments.
• Independently performs project planning. Establishes project objectives and priorities. Maintains an awareness of quality improvement and product opportunities and is productive in evaluating ideas and making proposals.
• Documents results, observations and conclusions in approved electronic files and prepares reports to communicate results to appropriate personnel. May train, counsel, and guide technicians, technologists, operation personnel, and engineers. Functions as an effective team leader and promotes harmonious and efficient working relationships.
• The job also requires performing other duties as assigned. Percentages of time spent on job duties are estimates and may vary for each position