Seble W. Afework Email & Phone Number

Oversight over Quality Assurance/Quality Control function in collaboration and QA/QC support specifically to products purchased for distribution to USAID sponsored countries for HIV/Aids, Malaria, Reproductive Health and Maternal and Child Health. Manage a team of 5 quality personnel.

Oversight over all functions of Quality Assurance and Compliance. Identify and implement key quality system processes for the organization. Responsible for setting up and maintaining the following quality systems: Document Control (SOPs, Specifications, Sampling Plans etc.), Materials Management, Change Control, Deviations/Investigations/CAPA system; Supplier Quality; Internal Audits and external audits; Environmental Monitoring; Training. Support validation and qualification activities. Provide cGMP training for the organization.

Perform supplier audit as a lead auditor or team auditor and support supplier quality management. Identify gaps, observations, and recommendations and communicate clearly to supplier. Generate audit reports and distribute to management and suppliers. Perform post audit activities to ensure investigations, corrective action plans, and effectiveness criteria are adequate and implemented.

Abbott Park, Illinois, Us

Prepared, planned and conducted audits to evaluate and verify compliance to internal and external requirements. Wrote audit reports and presented final results and findings including the assessment of compliance risks to senior management and debriefing sessions. Reviewed and approved investigations and resolution plans for CAPA, and ensured plans were implemented and effective. Audits covered were GLP studies, Clinical Research for GCP, Manufacturing and Manufacturing support activities for cGMP.

Abbott Park, Illinois, Us

Worked with Cross Functional teams and represented quality for Drug Eluting Stent project team meetings to provide guidance of drug regulations requirements from the inception of the project in design controls and research development to the final commercial product. Served as quality assurance guidance and helped to develop and incorporate drug quality system to the existing device quality management system. Worked closely with document control team to in reviewing and approving procedures to ensure compliance with change control processes. Served as quality engineer to support production floor for drug-device manufactured product and support analytical chemistry team to ensure compliance to quality system key processes.

Seattle, Washington, Us

Performed analytical testing on raw materials, in process, and finished products using a variety of technologies including HPLC, LC-MS, GC, GC/MS, FTIR, AA, UV and other wet chemical testing. Performed method validation on analytical test methods and transferred test methods to commercial QC group. Instrumental in transforming Nutritional testing lab to a GMP regulated testing lab. Used USP for testing certain raw materials.

Bs, Food Science & Technology/Chemistry Emphasis

Certificate Course, Clinical Trials & Management