Daniel Gamez Email & Phone Number

Memphis, TN, US

Gaithersburg, Maryland, US

Brentford, Middlesex, GB

Quality and Compliance oversight and end-to-end management of daily quality operations for key Contract Manufacturers in the North American region.

Brentford, Middlesex, GB

Provide oversight of quality and compliance for the manufacturing and packaging departments to ensure compliance to quality policies and regulatory requirements. Responsible for the management and support of Deviations/Investigations, Change Controls, CAPAs, Audits, Performance Management, Operational Documentation, Product Disposition decisions, and.

Brentford, Middlesex, GB

-Responsible for leading cross-functional investigations with Manufacturing, Packaging, and Engineering departments using the six-step approach to perform root cause analysis and define effective corrective and preventive actions.-Ensure product are produced in compliance with registered details, Technical Terms of Supply, regulatory standards, and company.

Brentford, Middlesex, GB

-Responsible for the site's Supplier Quality Program which included performing qualifying and monitoring audits on raw material suppliers and service contractors-Performed Supplier Quality Risk Assessments. -Managed quality information records within the SAP system.-Maintained and authored Quality Assurance Agreements and Product Requirement Specifications.

Brentford, Middlesex, GB

Responsible for reviewing batch records and executing product release. Responsible for performing Management Monitoring Audits. Documentation Deviations Metrics reporting. Responsible for tracking Non-Conformance Reports, Change Controls, and Laboratory Investigation Reports affecting batch release.

Marseille, Provence-Alpes-Cote d'Azur, FR

Responsible for overseeing all aspects of the Microsoft account relating to the transportation of goods and the maintenance of the client’s needs. Worked with Microsoft to establish detailed profiles and procedures that properly represented their order fulfillment and export process. Responsible for Customer Complaint Investigations. Created/Updated.

Memphis, Tennessee, US

Responsible for creating and revising re-packaging plans, rework plans, sub-assembly, and inspection plans. Reviewed, approved batch records, and executed product releases for the Merck Consumer Care/Bayer CH account making sure that they were in compliance with regulatory standards. Created and updated Standard Operating Procedures, and System Training.

Master Of Science, Regulatory Affairs For Drugs, Biologics, And Medical Devices

Bachelor Of Science (Bs), Packaging Engineering Technology & Engineering Management