Robexi Angeli

Experience

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  Rave Store, Cayey, Puerto Rico

  Jan 1984 - Jan 1985

  Assistant Manager

  • Ensure the business operations run smoothly in the shop• Keeping on track to meet the monthly budgets and targets• Provide training for staff and new recruitments• Planning rosters and duties for staff• Monitoring to assure excellent customer service

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  Treasure Department, Paseo Covadonga San Juán, Puerto Rico

  Mar 1991 - Jan 1995

  Security Auditor

  • Internal audits would collect around the island. Armored Truck Audits, Security Guard and Companies Security Alarm (ADT, Honeywell)

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  Municipality of Guayama, Finances Office and CRIM Office

  Jan 1996 - Jan 1999

  Accounting Assistant Auditor

  Audit and Maintenance of budget books, square of invoices, payroll, collecting municipal taxes.

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  Manpower Temporary Services Whitehall Robins, Guayama, Puerto Rico

  Jan 1996 - Jan 1996

  Manufacturing Operators

  • Processed formula ingredients to produce tablets/caplets granulations.• Produced tablets and caplets of acceptable quality from granulation using predetermined specifications.• Set up, operated and cleaned all compounder and compression equipment.• Used manufacturing Directions and applicable techniques to coat cores.• Performed in-process testing and records the required data.

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  Wyeth Pharmaceutical, Guayama, Puerto Rico

  Jan 1999 - Jan 2001

  Laboratory Analyst

  Wyeth Pharmaceutical, Guayama, Puerto RicoLaboratory 1999 – 2001 • Performed the following lab tests; Ultraviolet spectrometry, Infrared spectrometry, Thin Layer Chromatography, Dissolution testing, Potentiometric Titrations, Karl Fisher Analysis, Atomic Absorption Loss and Drying, Loss on Ignition and Other wet Chemistry Analysis.

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  Pfizer Pharmaceutical, Guayama, Puerto Rico

  Jan 2001 - Jan 2012

  Quality Assurance Specialist

  •• Manage the development, impact assessment and implementation of Quality Systems Directives.• Administrate development, revision, implementation and maintenance of all operating procedures. (Technical Writer)• Perform audits to the SOP manuals and forms.• Administrate and coordinates the GMP training. • Coordinate and supervise daily work generated by document management personnel.• Support quality audits in the manufacturing area and provide support during problem solving process. • Perform quality line releases (including cleaning verification) for manufacturing and packaging areas.• Initiate and support quality systems investigations.• Administer and follow up on the routing of Quality Standards (QSM/PQS).• Assist manager in direction, coordinate daily activities and serve as backup for the Document Management Manager.• Participate in special projects of the company, as advisor of procedures and other functions, as necessary.• Reviews batch records to ensure compliance with all material specifications, current Good Manufacturing Practices, Global Standards, Regulation and Quality Agreements before a batch is released. Supports the Cycle time reduction in batch records review and release• Audits areas of Quality System, such as Document Management and Regulatory Policies, as assigned. • Creates audit checklists based on assigned area, applicable regulations. Evaluates the adequacy and compliance of systems, operations, and practices against regulations and company documentation. • Follow up different departments for the completion of corrective action identified during Quality Systems Internal Audits.• Developed Microbiology equipment procedures for a new facility of Microbiology Laboratory at PCHC, special assignment for PNS Project. Mostrar menos

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  Business Excellence Consultant, BEC for Mylan, Caguas, Puerto Rico

  Oct 2012 - Oct 2013

  Documentation Operation Remediation Specialist Consultant

  • Redesign Master Formula Sheet according to regulation• Aligned Manufacturing Instructions according to FDA Commitments.• Optimize and Improve Instructions according to current manufacturing process flow.• Audit Master Formula Sheet to assure commitments with FDA are included.• Conduct Dry Runs and audit batch records in order to assure compliance.

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  Zimmer Biomet

  Jan 2013 - Feb 2019

  • Principally responsible for the Zimmer Document Control System. • Manages and coordinate all activities related with the revision, approved documents (Procedures, Forms), Publish final version, Distribute Controlled Copies and maintain master and history files.• Manage the development, impact assessment and implementation of Quality Systems Management (Corporate Control Documents Harmonization).• Manages and Coordinate the annual review process on a monthly basis for procedures.• Supervises Document Control Coordinators.• Manage expenses and cost according to the budget.• Conduct Quality Assurance Investigations determining root cause, and developing corrective action plans.• Manages the validation documentation area, assure the control of protocols generation and all documents related.• Manage Trident Project, Remediation initiative with multiple projects and goals, while facing strict deadlines.• Developed and executed process Validation related with Document Control System Implementations.• Provide guidance on new project teams as required, representing Documentation interests.• Responsible for internal and external distribution of new and revised documents to demonstrate compliance with GMP, ISO regulations. .• Manages and Coordinates responses in regard to procedure(s) status for external and internal Audit• Manages and coordinate all data entry and file maintenance is performed with a high degree of accuracy to maintain file integrity of electronic and hard copy files.• Manages and Coordinate the archival of Device Master Records and Device History Records to demonstrate compliance to GMP, ISO regulations.• Develop and Coordinate maintenance of various databases and procedures for the department. (Master Index)• Manages the deployment communication of external standards.• Develops, modifies, applies and maintains documentation to ensure compliance with quality standards.• See resume for Additional information Mostrar menos

  • Quality Assurance Supervisor

    Jan 2013 - Feb 2019

  • QA Supervisor Document Control

    Jan 2013 - Feb 2018
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  Baxter jayuya

  Feb 2018 - now

  • Assist in assuring the FDA readiness plan is maintained and executed as approved.• Provide support to the Quality Manager and Quality Auditor during the internal and external audits.• Prepare, review and revise SOPs, reports and other appropriate documentation related to inspection preparedness.• Assist in the preparation of the Front Room/Back Room practices and organization.• Perform interal audits, coordinate the resources to perform the audits in the Jayuya facility. Evaluate responces and provide followup on the audit closure. • Assist on the regulatory inspections (FDA, others), Clients, and Corporate Inspections. Assure that any observation is answered in a proper manner, and assure that any corrective actions are implemented. Mostrar menos

  • Consultant, BEC for Baxter, Jayuya, Puerto Rico FDA Readiness Specialist/Engineering

    Feb 2019 - now

  • Business Excellence Consultant - Remediation Specialist -FDA Readiness Quality Auditor at Baxter

    Feb 2018 - Feb 2019
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  Haleon

  Mar 2021 - now

  Consultant, Weil Group Caguas P.R. Manufacturing Documentation Specialist

  • Procedures development for new Manufacturing and Packaging equipment using manuals and in accordance with the validation and implementation process for the launch of Emergen C.• Revise SOPs to comply with CAPA, Change Control, Validation Reports, Periodic Review and EHSOne. (Technical Writer)• Perform CAPA Implementation.• Perform Risk Assessments Evaluation.