Tracy Sutton Email and Phone Number

Oversight of the validation program for production equipment and processes to support manufacturing of aseptic and terminally sterilized products. Provide technical leadership for deviation investigations. Assess new and existing equipment and processes (including documentation) against industry and company requirements to ensure compliance. Oversight of qualification strategies for projects. Collaboration with peers and stakeholders in Quality, Manufacturing, and Engineering for process improvement opportunities. Facilitate communication and implementation of consistent processes across various product teams and multiple manufacturing sites. Participate in development of strategic growth plans for the company.

Provide leadership in the execution of qualification activities for equipment, utilities, process, and cleaning. Review and approval of peer generated qualification protocols and reports. Responsible for technology transfer of products including generation of batch manufacturing and packaging records, identification of equipment train, scaling of batch size, and documentation to support regulatory filing.

Responsible for development and execution of life cycle documentation for manufacturing and packaging equipment, process validation, and cleaning validation. Instrumental in qualification of new serialization equipment. Accountable for initiating change controls and corrective/preventive actions (CAPA's) as needed.

Responsible for development and execution of life cycle documentation for manufacturing and packaging equipment, process validation, and cleaning validation.

Responsible for development and execution of life cycle documentation for manufacturing and packaging equipment, process validation, and cleaning validation.

Responsible for ensuring that projects adhere to cGMPs, internal procedures, client procedures, and GAMP as applicable. Directly responsible for development of customer proposals, growth of the local office, southeast region, and overall firm. Accountable for recruiting professionals, keeping them engaged on projects, and mentoring during their career path.

Responsible for project scheduling, resource allocations, financial tracking, directing validation professionals and developing customer relationships.

Responsible for ensuring Quality Assurance of life cycle documentation delivered to the client.

Responsible for development and execution of life cycle documentation and performing quality reviews of peer generated and executed documents.

Responsible for development and execution of life cycle documentation.

Summer Internship:•Performed QC in-process, finished, and stability testing of liquid pharmaceutical products.•Operated Analytical Equipment including HPLC, TLC, Karl Fisher, UV/Vis and IR.•Followed USP monographs and SOPs. •Followed Good Laboratory Practices (GLP) guideline.