Zeny Ortega

Background

About Zeny Ortega

Accomplished Quality Professional with extensive experience in pharmaceutical, biotechnology, and medical device industries: •Provided strong leadership and compliance oversight of the clinical drug product, API, reference standards, and commercial devices to domestic and foreign contract manufacturers. •Effectively managed the review and approval of master batch records, executed batch records, change control requests, deviations, investigations, certificates of release and manufacturing data, clinical complaints, stability data, CMC submissions, final packaging and labeling operations. Ensured that these activities are performed in a compliant and timely manner. •Efficiently managed the manufacturing quality operations including the batch disposition process. •Acted as a QA liaison and proactively led the cross-functional teams responsible for driving key development projects to completion, meeting critical timelines, budget, and corporate goals. Specialties: Over thirty years in Quality Management with expertise in Quality System Development and Improvement, Document Control, Training and Auditing, Batch Release, QA Compliance oversight, Data Review and Analysis, CMC submission support, Investigations, Batch Record/Change Control/Deviation/CAPA Review and Approval, Supplier Qualification, Incoming Material Testing and Release, Quality Engineering.