Senior Consultant
CurrentProvide QA support and regulatory advisement to the US Department of Health & Human Services medical supply chain logistics program and GMP repackaging, relabeling, storage, and distribution activities. Responsible for developing and implementing a Quality Management System for ISO 9001:2015 certification, including creating and/or revision of existing Quality Manual, Policies, SOPs, and Job Aids across the organization. Develop and assist implementation of quality assurance… Show more Provide QA support and regulatory advisement to the US Department of Health & Human Services medical supply chain logistics program and GMP repackaging, relabeling, storage, and distribution activities. Responsible for developing and implementing a Quality Management System for ISO 9001:2015 certification, including creating and/or revision of existing Quality Manual, Policies, SOPs, and Job Aids across the organization. Develop and assist implementation of quality assurance strategies that assess all aspects of the repackaging line and distribution operations such as receiving, storage, re-packaging, labeling, kitting, shipping, shelf life extension program and tracking recalls. Support Investigations, root cause analysis and implementation of effective corrective and preventive actions.Draft, review and/or advise on change controls, validations and risk assessments. Support identification and implementation of a 21 CFR Part 11 Learning Management System (LMS) to track, deliver and assess effectiveness of training. Review GMP records to ensure compliance with SOPs and applicable regulations. Show less
