www.apsol.uswww.noriskconsulting.comwww.devoutimage.comExtensive experience with pharmaceutical, OTC, medical device, and consumer healthcareproducts packaging systems in domestic and global working environments. • Participated in Verification meetings for Consent Decree Workstep completion • Worked closely with Consent Decree Workstep teams on the development, implementation and execution of remediation activities • Developed and executed remediation evidence documentation for Consent Decree • Developed and executed IQ, OQ, PQ, DP and many other validation activities of package handling systems for new products, product & equipment transfers, and new line installations • Developed and executed IQ/OQ, Commissioning, and other validation activities for facilities equipment, computerized systems and equipment, and formulations equipment and validation batches • Performed cleaning validation for new products to site and new to packaging lines • Decommissioned equipment and computerized systems for removal from service • Worked closely with suppliers, Regulatory, Quality Management, Purchasing, Operations, Planning, and Finance • Extensive use of statistical tools for analysis and reports • Managed cost improvement projects from conception to implementation for primary, secondary, and tertiary packaging designs and systems • Coordinated and implemented company standard test methods and utilized ASTM & ISTA methods on a daily basis • Developed and maintained specifications and bills of materials • Led and collaborated with cross-functional teams in new product launches • Developed and implemented new package designs • Managed all packaging issues for a large contract manufacturing site • Led and participated in many packaging line trials for multiple pharmaceutical product formats in a variety of package systems. • Familiar with cGMP, CPSC, and FDA regulations • Willing to travel as required