, procedures and practices as required. Support external and internal inspections through direct participation and resource...
and execution. This role has direct interaction with Regulatory Agencies during site inspections. Process Optimization: Develop...
site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections...
regulatory inspections Provide guidance to significant investigations and compliance gaps at site level Approve (or reject...
inspections of the property to identify maintenance needs and ensure safety standards are met. Respond promptly to maintenance...
meetings. Participate in corporate and regulatory compliance audits and inspections; interact with regulators, auditors... and customers during assessments; lead efforts to address gaps from these audits/inspections. Own and/or coordinate Process Safety...
technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain...
inspections. Process Optimization: Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean...
during regulatory interactions such as RtQ of submissions, and on-site inspections Responsible for maintaining a safe work environment...
technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain...
inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations...
and compliance consistency across plants; coordinate and manage regulatory inspections. Communicate to and strive for integration... during inspections regarding cGMP, environmental monitoring, and sterility issues. Network internally and externally to understand...
during site inspections. Minimum Requirements: Bachelor's Degree in Engineering, Science, or a related field. 5+ years...
activities Perform assigned facility inspections and due diligence efforts, reporting conditions that impact client occupancy...
and Inspections: Manage C&E inventories and walkthroughs, and perform spot-checks on our inspections. Technical Support: Assist...