Quality Assurance Raw Material

OMOTAYO OGUNYEMI 336-***-****

Oxford, GA *********@*****.***

A visionary leader and organized take-charge strategist demonstrating a solid pharmaceutical quality career interspersed with research, capacity building, and quality assurance. Solid knowledge of pharmaceutical raw material and component quality supply. Versed in material risk assessment, quality control, equipment validation, and generating and presenting reports to leadership. Proven success in managing multiple large-scale projects across matrix environments and multi-phased, complex programs that address people/organization and process change.

• Demonstrate +13 years of professional experience working in pharmaceutical manufacturing, material quality supply, and equipment validation as well as 5 years of educational experience in Public Health, Epidemiology research, and data analysis

• Subject matter expert in FDA, USP, EP Guideline for Raw Material and Filter Qualification, installation Validation and Operation Qualification, and Process Performance Qualification

• Ability to promote innovations and provide scientific leadership in the drug development process through collaborative work with the industry, academia, and domestic foreign agencies and organizations.

• Analyze the methods used to plan, develop, implement, evaluate, and revise epidemiological research studies; and examine epidemiological research principles, including disease occurrence measurements and risk calculation. Versed in viral robotic cell culture, purification, and harvesting System

• Lead multidisciplinary teams in the development of reports, prototype tools and methodologies, and lead presentations for both lay and professional public health audiences that communicate findings, provide innovative solutions, and promote recommendations to improve efficacy

• Material Quality supply

• FDA, USP, and EP specifications Compliance

• Quality Assurance Compliance

• Project Management and process improvement

• Data Integrity and ALCOA Compliance

• Installation Operation Qualification (IOQ)

• Proficient in ValGenesis usage for generating and executing the protocol.

• Staff Supervision & Development

• Team Building & Leadership

• Equipment Qualification/ Validation

• EBM/MES/SAP/DELTA V

• Performance Qualification (PQ)

• Performance Evaluation

• Reports & Documentation

• Sterility Assurance

PHARMABIO-SERVE (ALCON)

Sr. Validation Engineer Lead (Consultant). July 2021 – Nov 2023

• Led validation engineer consultant team on qualification of the Injection Molding Machine, curing and casting machine, extraction equipment, inspection and primary packaging equipment.

• Authored and executed equipment IQ/OQ protocols, refrigerator IOQ, technical reports, and traceability matrix.

• Authored and execute utility qualification protocol for compressed air, secondary chill water and commissioning of the dust collection.

• Performed deviation investigation and resolution for deviations encountered during protocol execution activities.

• Proficient in ValGenesis usage for authoring and executing equipment qualification protocol.

• Reviewed user requirements, P&IDs, and SOPs.

TAKEDA PHARMACEUTICAL (FORMERLY SHIRE)

Quality Validation- Professional II Apr 2017 – Jun 2021

• Exceeded expectations in driving corporate growth through quality review and support for equipment validation, process and automation system validation, and Electronic Batch Management (EBM) while tracking changes in compliance with regulatory standards and divisional procedures.

• Led execution of raw material and filter qualification projects from concept to completion time, scope, and quality parameters

• Performed equipment, raw material, and component qualification, reviewed and authored functional specification documents, review User Requirement Specification and Design Specification as well as testing protocols and test reports including Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).

• Led data integrity global project for equipment and systems as well as steered quality validation processes involving the assessment and approving test protocol, deviation, and CAPA. SELECTED CAREER ACHIEVEMENTS

CORE SKILLS

PROFESSIONAL EXPERIENCE

PHARMACEUTICAL Validation and Material Quality Supply Consultant Delivering Transformation, Excellence & Growth Leadership

• Participated in the successful execution of internal and external regulatory inspections SHIRE PHARMACEUTICAL (FORMERLY BAXTER/BAXALTA) Aug 2014 – Apr 2017 Material Qualification Lead

• Championed harmonization of site-wide material and Component qualification process. Authored Filter Qualification validation plan, component qualification, and Raw Material Qualification program

• Performed risk assessments and tracked regulatory standards and divisional procedure changes that impacted service efficiency

• Analyzed material qualification data and executed all necessary tests in adherence with FDA, USP, and EP specifications

• Harmonized the material qualification processes in partnership with the company's Global material qualification team in Europe and the United States: facilitated material risk assessment, extractable leachable risk assessment, and failure mode effect analysis (FMEA).

• Identified raw materials and components with direct or indirect product contact focused on optimizing the products' safety, identity, strength, potency, quality, and efficacy

• Led raw material and filter documents verification and equipment qualification as regards the Factory acceptance test (FAT), as well as authored FAT execution protocol, performed equipment walk down, and prepared the final FAT report

• Coordinated the entire equipment performance qualification process for FIT (Filter Integrity Testing), coordinated filter integrity test training, and FIT execution process

• Promoted corporate growth through effective management of filter qualification program involving the filter selection for manufacturing operations in alignment with usability while fostering a solid relationship with an external vendor to gather qualification data for filters used on site

• Performed analysis on the filter qualification documentation and generated company filters using the obtained qualification data for filters used on-site

PFIZER (FORMERLY HOSPIRA) Jul 2013 – Aug 2014

Biological Quality/Environmental Control (QA/QC) Supervisor

• Modernized capabilities within the organization through efficient management, scheduling, prioritization, and coordination of workflow for Analysts in the microbiology laboratories as well as oversaw the quality control employees in evaluating raw materials, in-process production, and finished product testing

• Acknowledge for stellar success in providing prompt resolution to personnel issues within the laboratory work in adherence with standard regulations

• Accelerated growth in upholding quality standards for operational procedures through optimizing active testing processes and implemented initiatives for optimal efficiency

• Examined and evaluated analytical test data to ensure maximum compliance with specified quality standards while also remediating all identified environmental sampling issues with the demeanor and utmost professionalism MERCK SHARP & DOHME Aug 2010 – Jul 2013

Senior Bio- Process Technician Lead

• Performed real-time review of electronic batch records and GMP documentation.

• Assigned, coordinated and oversaw processing responsibilities of technicians, and tracked training progression daily

• Identified processing and procedural deviations and performed investigations to ensure effective corrective actions are implemented. revised, approved, authored operation procedures, and GMP documents

• Performed personnel and equipment Environmental Monitoring during manufacturing processing and facility requalification.

• Participated in the medial fill process and equipment qualification. LABCORP DURHAM, NC Lab Technician Jan 2008 - May 2010 NORTH CAROLINA CENTRAL UNIVERSITY (BRITE) DURHAM, NC Research Student Aug 2008 - Dec 2010 Eko Club International Chief Liaison Officer 2019 –Present Red Cross Government Operation and Disaster Responder 2017 - 2019 DrPH, Epidemiology Dec 2020

CAPELLA University Minnesota

MBA in Healthcare Management Dec 2015

WESTERN GOVERNORS UNIVERSITY Salt Lake City, UT

B.S. in Pharmaceutical Sciences, Minor in Chemistry Dec 2010 EDUCATION

PREVIOUS WORK SERVICE

COMMUNITY EXPERIENCE & PROFESSIONAL MEMBERSHIP

NORTH CAROLINA CENTRAL UNIVERSITY (BRITE) Durham, NC A.S. in Science A.S. in Applied Science in Biopharmaceutical Technology 2007/2008 WAKE TECHNICAL COMMUNITY COLLEGE Raleigh, NC

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