Gldavis Quality Consultant
CMO (Remote Consultant) @Johnson & Johnson
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WORK HISTORY
CMO (Remote Consultant) @Johnson & Johnson
Review and approve master batch records, master labeling/packaging records, product specifications, stability protocols, stability reports, and other process related documents from contract sites-Perform batch disposition through batch record and data review/approval and managing process deviations for timely release-Review and/or approve deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events-Review and approved manufacturing batch records, aseptic qualification protocols and reports-Assist in the development and tracking of Quality metrics. Prepared metrics for the Management Review and Annual Product Review-Proactively and effectively communicate with contract manufacturers to address and resolve complex and routine activities while building positive client/vendor relationships, fostering continuous improvement, and adding value to our internal CMC team-Provide Quality Assurance leadership, guidance, and direction to CMOs consistent with cGMPs and quality compliance.
EDUCATION
St. Petersburg College
Business Administration, Business
Dunedin Senior High School
Hjgh School Diploma, Basic Education
ABOUT GLDAVIS QUALITY CONSULTANT
Independent Task Driven Senior Quality Assurance Consultant with over 25 years working in…
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