Donna Kucsma
Associate Director, QA Systems Management at Daiichi Sankyo, Inc.
- Role
- Manager, Qa Commercial Gmp at Daiichi Sankyo US
- Location
- Caldwell, NJ, US
- LinkedIn followers
- 500 followers
Experience
Manager, Qa Commercial Gmp
Aug 2011 — Present · Basking Ridge, NJ, US
Manage the complaint process for clinical and commercial complaints, including Quarterly Product Complaint Reports. Manage Trackwise modules as the Computerized System Owner for Trackwise and associated processes. Interact regularly with CMOs regarding various Quality needs and issues, such as investigations and deviations. Review documentation supporting CMO changes to manufacturing, packaging and quality control processes and procedures, including batch records, CoAs, manufacturing orders, packaging instructions, various specifications, SOPs, and test reports to ensure changes are in compliance and to ensure efficiency of the approval and implementation of the changes. Review documentation supporting Labeling changes, including PIs, bottle labels, cartons, and packets to ensure changes are in compliance. Research investigations, develope preventative measures and contribute to the timely closing of the investigations. Core team member and SME for the development and implementation of all TrackWise modules. Develop training materials and train new and existing employees on the TrackWise System. Prepare and maintain Annual Product Reviews.
Education
Rutgers University
Bachelor of Arts (BA), Majored in Criminal Justice and Psychology
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