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 appropriate records of all work performed following GMP/GLP guidance documents.

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. Responsible for performing data analysis for monthly metrics reporting of quality related data. Perform root cause analysis of nonconforming products with Quality, Production and Engineering leadership using established tools and principles, track corrective actions, and ensure closure of NC to meet monthly metrics.

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 in External Audit Processes (Customers, Regulatory Government Agencies, etc.) and Internal Audit Processes (Laboratory, Warehouse, Facilities, Production, etc.).

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 R&D/Technical Services/Validation/Engineering Project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements. Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines). Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production. Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times. Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities.

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 approves Quality Events investigations and CAPA’s. Assists in the Supplier Qualification/Certification program. Participates with the QA & Compliance Department on Regulatory inspections and internal company audits.

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 SOPs and Validation reports. Participate and review Quality Risk Assessments (QRA). Participate on New Product Introduction (NPI) teams

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 Investigation through the interaction with multidisciplinary teams; MFG, Pack, Technical Services and Quality. Support the Initial Assessment and Investigation completeness timeline.

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 SOPs and Validation reports. Participate and review Quality Risk Assessments (QRA). Participate on New Product Introduction (NPI) teams.

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; provide guidance to the MFG, Pack and Lab Non-conformance Reports through the investigation, review and approval of Non-conformance Reports. Evaluate Non-conformance Reports to ensure the Root Cause Analysis and the CAPA assigned will correctly address the situations. Support and Interact with multidisciplinary teams from Manufacture, Packaging, Technical Services and Quality personnel through the Non-conformance Root Cause Analysis. Review Interim Reports and Protocols for a Batch Record Remediation Project.

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 guidance to the MFG, Pack and Quality area personnel for the final review and approval of Batch Records. Interact, support and provide guidance to the MFG, Pack and Quality area personnel for the review and approval of Non-conformance events.

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 standards and regulatory requirements, interact, support and provide guidance to the MFG, Pack and Quality area personnel for the proper correct evaluation, documentation and approach to non-conformance deviations. Review and approve Quality Assurance Evaluations forms.

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 meetings. Review and approve new or revised SOPs from the MFG and Pack areas. Identifies, reviews, and approves Planned and Unplanned Deviations. Assure Certificates of Analysis (COA) meet the Product and Method Specifications. Approval and disposition of Raw Materials, Packaging Components and Finished Product on an inventory system program. Prepare, keep and communicate performance metrics and reports for all site departments. Evaluate and recommend improvements on approved Laboratory Non-conformance Reports on COA’s. Participate as a member of Quality Assurance in the plant Annual Training Program as a subject matter expert (SME). Prepare and review the Annual Product Review (APR). Participate on internal and external organizational Quality Audits. Provide support in the transfer of new equipment technology. Experienced liaison between Third Party Packaging facility and the site, through a blockbuster launch of a new international product. Identifies Review and approve non-conformance deviations of SOPs, quality standards and regulatory requirements from Third Party Packaging facilities process. Provide support and guidance to Third Party facilities areas, such as to Packaging, Quality and Manufacturing personnel, regarding the proper evaluation, documentation and approach to identify process non-conformance deviations.

Bachelor, Education - Biology

Master, Industrial / Organizational Psychology