System Design Data Integrity

Part ** & Data Integrity SME

Senior Consultant, with over 34 years’ experience. Part 11 SME / FDA Mock System Audits / Integrity Gap Analysis / Sterile & Non-Sterile Finished Drugs and APIs / FDA 483 and Warning Letter Response Review / Integrity and OOS Training / 3rd Party Audits.

PROFESSIONAL EXPERIENCE

Emergent Bio MA, 2022

Aseptic Oversight SME

Key Achievements:

• Identified gaps and delivers training programs to drive a Quality Culture

• Advised and consults on project Quality, Qualification and Validation approaches

• Performed Aseptic Oversight & Monitoring Checklist

ThermoFisher Greenville NC, 2021

System Design Specification SME

Key Achievements:

• Performed System Design Specification of the new manufacturing line facilities for Moderna (Covid-19)

• Verified all packaging drawings of the new manufacturing equipment

• Verified all System Design Specification comply with (21 CFR 210 / 21 CFR 211)

Pfizer Toluca Mexico, 2021

Validation Engineer SME

Key Achievements:

• Provided validation leadership on design, commissioning, start-up, and qualification of control systems supporting manufacturing.

• Reviewed protocols to ensure that technical and regulatory requirements are met.

• Generated, revised, and execute Validation protocols and reports based on specifications, and drawings

• Performed and reviewed specifications, drawings, and commissioning testing to ensure they meets the requirements.

• Verified deliverable such as: User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications, Trace Matrixes (TM), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Summary Reports (SR), Project Validation Plans (PVP).

• Reviewed Validation requirements and developed strategies to prevent deviation (Gap-Analysis)

Strides Shasun India, 2019

Data Integrity SME

Key Achievements:

• Support the Data Integrity Gap Assessment of GMP areas in scope of the program and ensure compliance with policies and standards.

• Ensure GxP computer systems are designed, validated, and maintained in an appropriately risked based and compliant state throughout the entire systems and data lifecycles.

• Monitors, tracks and trends findings/corrective and preventive actions resulting from system audits.

• Hands on Experience in Incident, Change and Release Management for GxP Systems

• Conduct Root cause Analysis for the deviations

• Create, Update RRA (Regulatory Risk Assessment) and obtain approvals

• Migration of Track wise Systems from On-Prem to Cloud (Trackwise Digital)

• Experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the pharmaceutical industries.

• Support internal and external (regulatory) inspection activities related to validated systems

• User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) .

• Excellent Knowledge and experience in Good Documentation Practices.

Teva Pharmaceuticals FL, 2019

Manufacturing Improvements SME

Key Achievements:

Manufacturing SME:

• Provided effective leadership in supporting quality and Manufacturing disciplines, decisions and practices

• Mentor Quality and Manufacturing professionals such as (Manufacturing and QA) in the following requirements: cGMP, 21 CFR part 11, 21 CFR part 210 and 21 CFR part 211

• Serve as a SME for manufacturing operations during Agency inspections (FDA) and as needed during Quality Audits

Pfizer NC, 2019

Quality System Improvements SME

Key Achievements:

• Experience in developed and improvements Quality documentation such as electronic Standard Operating Procedures, Power Point and Excel graphic

• Recommends improvements in Formulation and Aseptic Areas

Thermo Fisher Scientific NC, 2018

MQA Consultant

Evaluated and define the requirement to support Quality Risk Assessment as follow:

Key Achievements:

• Identified client organization’s strengths/weaknesses and suggests areas of improvement

• Evaluated and define the requirement to support Quality Risk Assessment such as: Critical and major events, Excursions and CAPAs

• Developed assessment and review of risks to the quality of the drug product across the product lifecycle

Pharma Quality Europe Florence Italy, 2017

PM Freelance Consultant

Managed a Validation group and provide support in areas such as: 21 CFR Part 11, CSV, Trackwise Quality Management System app, Maximo app and Blue Mountain app

Key Achievements:

• Lead client kick off meetings

• Performed risk assessment and analysis of project deliverables in conjunction with the Client and the operational project team

• Monitored the project budget and maintains all milestones in PeopleSoft so that appropriate invoicing and revenue recognition can be accomplished in a timely manner

Pharma Quality Europe Florence Italy, 2017 (Continued)

PM Freelance Consultant

• Established full project plans including timeline, risk assessment, contingency planning and communication planning

• Performed full project review to ensure that all project deliverables have been met and all financial aspects have been completed

• Managed Planning data sent by Project Accountant

Mylan India, 2015

Senior QA Engineer & Remediation (Consultant)

Provided Quality-Engineering Support to Remediation Plan & FDA Audit

Key Achievements:

• Verified trending data, analysis report, makes recommendations and drives programs to improve products and processes in Remediation Plan & FDA Audit

• Identified gaps and delivers training programs to drive a Quality Culture

• Conducted internal Quality System audit to different areas as follow: Manufacturing, Sterile Area, Engineer Department

• Lead and facilitate cross-functional teams to deliver aggressive plans in attainment of project goals

• Identified client organization’s strengths/weaknesses and suggests areas of improvement

• Builds effective relationships with a variety of clients; gains their confidence and support

• Reviewed product and process transfer plans, making recommendations for changes and/or improvements

Pfizer Carlisle PA, 2015

Senior QA Engineer (Consultant)

Provided quality-engineering support to new facility and transfer equipment in the areas of Design, Process Validation, Risk Management and Specification. Performed Gap Assessment and Full Life Cycle to existing BMS

Key Achievements

• Reviewed documentation and technical specifications of new applications in order to develop Test Plans, Test Scenarios and Test scripts

• Provided Quality oversight to Software Verification & Validation Program to (BMS)

• Developed Gap Assessment and Developed Process Mapping,

• Developed Installation and Operational Qualification to Blending room area

• Provided support to development, engineering and manufacturing functions for validation planning and transfer activities

Rescop Eindhoven Netherlands, 2014

Senior QA Engineer (Consultants)

Provided quality-engineering (SME) and Performed Full Life Cycle of Laboratory Equipment, Manufacturing Systems and Processes. Developed Installation Operational Qualification to existing Blue Mountain Calibration Manager. Writes, develops and executes procedures and /or protocols. Developed Process Mapping, Thermocouple Calibration and Temperature Mapping Study

Key Achievements

• Developed Installation and Operational Qualification / Thermo Scientific Revco Refrigerator REF-51C

• Developed Installation and Operational Qualification / Harris Environmental Chambers Incubation Room

• Developed Installation and Operational Qualification / Blue Mountain Calibration Manager Application

• Performed pre and post review and approval of validation test scripts and documentation deliverables such as: Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix and Reports

Maquet Inc. Wayne Nueva Jersey, 2014

Senior QA Specialist (Self Employed)

Responsible for the development and implementation of regulatory strategies and reviewed documents for compliance with established standards and policies

Key Achievements

• Reviewed current departmental SOPs and suggest and draft new SOPs

• Facilitated policy and development of standard interpretation of global regulation

• Participated in cross functional team activities from initial stages through securing government approvals

• Established and maintain regulatory information systems both electronically and hard copy

• Interface with project team members to obtain documentation, establish timelines and ensure complete and accurate submissions are made according to plan

• Reviewed documentation intended for submission to the FDA for internal consistency and against any relevant guidelines

Patheon Mexico DF, 2013

Project Manager MQA (Self Employed)

Managed a fully functional Process Validation group and provided QA support responsible for implementation, enhancement and maintenance product system validation and Process equipment qualification

Key Achievements

• Responsible for executing the long-term strategy of the Company’s Quality Systems, incorporating best practices while maintaining alignment to Company Objectives

• Implements and maintains the Corporate Operating Procedures and centralized processes and templates, identifies and implements process improvement tools for Quality Systems to ensure the process requirements of Quality Compliance systems integrated.

• Reviewed Validation requirements and developed strategies to prevent deviation (Gap-Analysis)

• Trained Technology Departments in Qualification activities.

• Designed, developed and implemented Deviation Management, Change Management, Record Management and CAPA Programs.

Sanofi Pasteur PA, 2013

Product Transfer SME Consultant

Managed a fully functional Product Transfer (Polio Vaccine) Qualification and Process Validation activities

Key Achievements

• Provides Process Design Engineering to R&D, Manufacturing and Product Development

• Assists with process flow documentation, design process steps workflow and material handling techniques

• Assists with R&D protocols for new product introduction

• Provides analysis of manufacturing processes development, process improvements and validation

• Developed Small Scale Stability / Developed Equipment Qualification

• Formulation Process Design

• Developed Manufacturing MBR

Quintiles NC, 2011-2012

Quality Oversight Manager (Self Employed)

Review Lifecycle documents, Assessments, Internal Audit, Qualification Protocols, and Summary Reports including, but not limited to:

Key Achievements

• Serving as interim QA Manager and Manufacturing Quality representative to facilitate the achievement of quality goals

• Designed and developed checklist for internal audit

Quintiles NC, 2011-2012

Quality Oversight Manager (Continued)

Key Achievements

• Provide GMP compliance consultation and coaching/mentoring for continuous improvement

• Provide oversight monitoring/verification to ensure that processes and associated controls are executed and documented correctly

• Reviewed and revised departmental SOPs

• Identify opportunities for process improvements and support remediation/implementation

• Designed, developed and implemented Deviation Management, Change Management, Record Management and CAPA Programs

• Review Validation Plans and Protocols and ensured products met required needs

• Reviewed Validation requirements and developed strategies to prevent deviation (Gap-Analysis)

Wyeth Guayama PR, 2007

Project Manager CSV / IT (Consultant)

Responsibilities included: Prioritized, Managed and executed multiple projects utilizing Project Management methodology and builds effective relationships between Quality Assurance and project team to assure that GxP software is implemented in compliance with applicable regulations and guideline

Key Achievements

• Performed strategies and developing documentation for deliverables such as Validation Master Plan, CSV, Regulatory Risk Assessment, Validation Protocols (IQ, OQ, PQ), URS, FRS, Requirement, Traceability Matrix (RTM) and Validation Summary Report

• Provided an assessment of client computer systems in terms of GxP compliance

• Planed, scheduled, executed and lead pharmaceutical validation project assignments including: implementation of new systems, remediation of legacy, and re-validation of existing computerized systems

Wyeth Guayama PR, 2007 (Continued)

Project Manager MQA CSV / IT (Consultant)

Key Achievements

• Expert (SME) knowledge of regulations (cGMP / FDA 21CFR Part 11/ Good Automated Manufacturing Practice (GAMP5) and current industry practices in hardware/software validation and computerized systems

• Experience performing GxP audits, customer audits / ASQ certification

• Worked knowledge of asset management of Servers (commissioning, SAT, FAT and decommissioning)

• Expert (SME) knowledge of Network Infrastructure: routers

• Hands on experience auditing, qualifying or validating Cloud computerized systems

• Performed and executed plan schedule and lead pharmaceutical validation project assignments including: implementation of new systems, remediation of legacy and re-validation of existing computerized systems

Key Achievements (Continued)

• Participated in the full lifecycle of Computer System Validation protocol documents (draft, review, revise, finalize, execute, summarize)

• Resolved problems during validation process and address/advise on issues such as deficiencies, deviations and change control

Roche Diagnostics PR & Indianapolis, 2006

Project Manager CSV & 21CFR Part 11 Requirements (Consultant)

Key Achievements

• Developed system classification, {IOQ} and {PQ} to Agilent 1200, Culligan RODI System Water and Microcentrifuge Eppendorf 5810R and 5415D

• Develop assessments to Part 11, {IOQ} to DU WinConnetion software Suite and TotalChrom software.

• Developed Laboratory SOP, Traceability Matrix and Final Report.

• Performed as part of the validation but not limited different test such as: Critical Screens with valid/invalid data entries, Critical alarms and error messages, Confirmation of appropriated power failure responses, Challenging system security testing multi-users access, testing communications reliability between the computer and interfaced system, testing backup and recovery procedures.

• Coordinates meetings and assure all CSV validation activities established are completed at the time requested such as: Requirements Specification, Design Specification

• Develop Laboratory Equipment Qualification such as: Equipment System Identification, Equipment System Description, Intended Use Classification, Equipment System Requirements, Validation Requirements

Wyeth PR, 2005

Project Manager CSV/ Track Wise (Consultant)

Key Achievements

• Review all validation plans, perform system validation and create validation documentation as necessary

• Identify, train and manage contractors who perform qualification/validation/data migration activities in accordance with the CSV methodology

• Assist in efforts to continually improve CSV methods using compliant, efficient, and risk-based approaches

• Manage the lifecycle of documents such as procedures, instructions, change control, and validation documentation within IT to ensure proper and timely review

Ensure activities and deliverables are in compliance with both company quality assurance standards and applicable government regulations, such as FDA and ISO requirements

• Developed and challenge Test Methods {IQ} Installation Qualification such as:

• Documentation verification Test

• Training Verification Test

• SOPs Verification Test

• Utilities Verification Test

• Calibration PM and Spare Parts Verification Test

• Environmental Conditions Verification Test

• Hardware Installation Verification Test

Key Achievements (Continued)

• Developed and challenge Test Methods {OQ} Operation Qualification such as:

• Application Security Verification Test

• Operating System Security Verification test

• Application Time Out Period verification Test

• Screen Navigation Verification Test

Pfizer PR, 2004

Product Disposition & Change Control Consultant

Reviews batch records for proper documentation and assure they are in accordance with in process and evaluation forms, Identifies deviations and request corrections, assign expiration date for packaging products, as established for each container/closure style, reviews certificate of Analysis CoA, assure stability samples are taken as per Marketed Stability Program.

Key Achievements

• Evaluate the impact that proposed changes will have on products, processes, facilities, utilities, to ensure risk minimization and ongoing regulatory compliance.

Pliva NJ, 2004

Senior Compliance Consultant

Key Achievements

• Created & Revised Methods and Specification to R&D

• Created SOP’s for new product

• Knowledge of title 21 CFR Part 11 code of Federal Regulation.

• Develop Validation Plans, User requirements Specification {URS} and Functional Requirements Specification (FRS).

Watson Laboratories FL, 2001-2002

Senior QA

Key Achievements

• Create and maintain an audit schedule for document Files and Binders. Performed document-training record. Verified technical data for Production, such as sterilizer Cycle Printouts and Equipment Logs and Batch Records.

Eli Lilly PR, 2000

Senior QA

Key Achievements

• Verified batch records and environmental data were generated in manufacturing areas.

• Provide services to maintain and control Master Record Documents.

Environmental Technician

• Performed manifest of non-hazardous waste material for destroyed out of plant and continuous tracking system.

• Created monthly reports such as: DEA 41 and DEA 222 forms to control substance.

Amgen Pharmaceuticals PR, 1999

QC Laboratory Technician

Key Achievements

• Performed analysis using different equipment such: as analytical balances, TOC, buffer preparation, ph and conductivity meter.

• Perform calculation and dilution.

• Responsible for assembling and disassembling processing equipment, maintain all data generated in the global Laboratory Information Management System or LIMS.

Lead the PH test in the Lab. to new water system and work closed with team member of Validation Department to coordinated and assures the process of sampling plan for integrity test.

Warner-Lambert Inc. PR, 1998

Environmental Technician

Key Achievements

• Created and updated standard Operating Procedures taking into account environmental considerations to comply with Local and State Agencies, laws and company policies.

• Coordinated meeting with external contractors thus giving extra support and feedback to our environmental guidelines.

• Revised and created environmental statements to the job description for assure a safe place to the employee.

Alcon Labs PR, 1992-1997

Senior QA

Key Achievements

• Prepare and operate Batch Optimization tank according to SOP`s

• Set-up sterilization components and process equipment

• Verified the weight and preparation of chemicals to be used in formulation

• Verified environmental data

• Performed Filter integrity test

• Performed sampling tank in aseptic area

• Performed routine assay in formulation and filling areas such as: LAL, Touch Plate, Rodac, SAP, Swabs, Particles test

EDUCATION AND CREDENTIALS

Interamerican University of Puerto Rico 1990 to 1991 San Juan, PR

Advanced Studies

• Specialization: Microbiology

Interamerican University of Puerto Rico 1985 to 1989 San Juan, PR

• BS Biology

National Computer College 1984 Fajardo, PR

• Computer Program & Code

PROFESSIONAL MEMBERSHIPS, ORGANIZATIONS, AND PUBLICATIONS

Memberships:

• American Society for Quality (ASQC)

• Document Lifecycle Administration (Wyeth PR)

• Infrastructure Installation Testing (Wyeth PR)

• Infrastructure Protocol Creation (Wyeth PR)

Social Network:

www.linkedin.com/in/reicru

REFERENCES, RECOMMENDATIONS, DETAILED CASE STUDIES

Furnished upon request.

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