Anna Hamilton Email & Phone Number

Alameda, California, Us

Basel, Ch

Grifols aquired Novartis in 2014-Managed the Third Party (3PL Distributors/ Commercial Launch) Quality program including qualification of new Third Parties, initiation of Quality Questionnaires, quality audits, quality agreements, risk assessment and risk mitigation documentation, change control, 3PL/ commercial distributor performance monitoring, investigations (deviations and complaints) and other maintenance or exit activities.-Certified Quality Trainer- Developed Quality Management/ customer focused programs such as complaint handling and deviation management with Third Party Contractors.- Provided support for the management of all regulatory (Health Authority) inspections, customer or other external audits as well as responses and follow up actions.-Performed Change Control evaluations and implement actions for the approval of new Third Parties, suppliers/materials or service providers or implementing the disqualification of contractors.

Basel, Baselstadt, Ch

-Responsible for QA activities for blood testing medical device product launch, product material acceptance, product inspections, product disposition, product investigations and non-conformance trending. -Assisted in the development of the Supplier/Vendor Management Quality Qualification and Monitoring Program.-Provided GMP, ISO and associated OJTtraining to Quality Assurance staff and other departments as needed to facilitate improved high quality performance.-Performed statistical trend analysis on non-conforming materials and discrepancy reports for the purpose of implementing a compliant material acceptance program, resulting in a cost saving of over $900k.-Direct supervisor of 2 permanent employees.

Basel, Baselstadt, Ch

-Core team member, representing QA, on new Medical device (assay, instrumentation, and software) design control teams, resulting in liscensed commercial launches.-Managed project design history file and device master record.-Performed product inspection and disposition activities for all commercialized medical devices (assays and instrumentation).-Wrote and reviewed validation protocols and final reports, product requirements, and specifications.-Principal QA reviewer for all product website materials for promotional compliance.