Heckson Maldonado Email & Phone Number

Basel, CH

Vero Beach, FL, US

Responsible for providing independent quality review of operations pertaining to the manufacturing of drug product. This position provides QA expertise and support to ensure processes maintain compliance with current GMPs, regulatory standards, and internal procedures. Follow procedures and guidance associated with GMP/GLP and data integrity. Maintain.

Clearwater, Florida, US

Provides quality support for the business to ensure that the quality of the raw materials received, and products manufactured meet defined product specifications through defined inspections. Asist t in the investigation of manufacturing issues and supplier NC support of the business, including the use of test equipment and inspection techniques..

Largo, FL, US

Assure individual compliance with FDA regulations, cGMP’s and all other applicable international regulatory compliance requirements. Coordinate maintain and managing processes for the Qualification of VistaPharm Suppliers. Coordinate and participate on Supplier Audits to ensure suppliers meet VistaPharm Suppliers Qualification Program requirements. Engage.

Somerset, NJ, US

Primary quality liaison for clients and internal customers, Subject Matter Expert for the client products, processes and requirements. Effective coordination of functions across the site and with clients to drive timely review, approval and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks. Participates in.

Raleigh, NC, US

Responsible for the online review associated to all manufacturing and packaging process, batch records and approve from Quality standpoint assuring that manufacturing activities are carried out within the framework of corporate/governmental policies and regulations (cGMP’s). Subject Matter Expert (SME) role from the Quality perspective. Evaluates and.

Guaynabo, Puerto RICO, US

Maintain the audit readiness of manufacturing building, supports filling areas by assuring Quality compliance and adherence to the Manufacturing Standard Operating Procedures (SOPs), support on the evaluation and approval of non-conformance events. Review and approve product Manufacturing Paper (MP) and Manufacturing Orders (MO). Review and approve site.

Guaynabo, Puerto RICO, US

Responsible for the initiation and performance of nonconformance events investigation from Manufacturing and Packaging areas. Support the Operations Compliance Department through the Non-conformance Reports preparation to ensure the Root Cause Analysis and the CAPA assigned will properly address the nonconformance event. Support the Non-conformance.

Maintain the audit readiness of manufacturing building, supports filling areas by assuring Quality compliance and adherence to the Manufacturing Standard Operating Procedures (SOPs), support on the evaluation and approval of non-conformance events. Review and approve product Manufacturing Paper (MP) and Manufacturing Orders (MO). Review and approve site.

Guaynabo, Puerto RICO, US

As Validation / Change Control Specialist; support an initiative of Continuous Improvement through Remediation Projects. Support in the preparation, review and initiation of Change Control through its approval and implementation. As QA Specialist; support the Quality department in the completion of FDA Agency agreements and requirements. As QA Reviewer.

Support the MFG and Packaging areas in the reviews MFG and Packaging Batch Records. Identifies Non-conformances, recommend, review and assure that proper Non-conformance Root Cause Analysis and CAPAs shall be granted prior approval. Support Final Release of products with QUANTIC Group, under site Consent Decree agreement. Interact, support and provide.

Cambridge, Cambridgeshire, GB

Support the updating of Stability data in the Commercial Stability Management operating system, issue and activate Stability Studies and Stability Protocols within GLIMS and ensure the stability studies are retrieved according to schedule from the environmental chambers and delivered to the laboratory.Identify non-conformance deviations of SOPs, quality.

Reviews Mfg and Packaging Batch Records. Identifies Non-conformances, recommend, review and assure that proper Non-conformance Root Cause Analysis and CAPAs shall be granted prior final approval. Participate as a member of QA and Compliance departments at multidisciplinary teams through the non-conformance investigation process. Represent QA area in staff.

Bachelor, Education - Biology

Master, Industrial / Organizational Psychology